m a y/ j u n e 2 0 2 2 | v o l 5 n o s 1

Psychedelics:
New Frontiers
in Alternative
Medicine

www.cannabissciencetech.com
PSYCHEDELIC
DRUG DISCOVERY
EXPLORE RESEARCH COMPOUNDS
& ANALYTICAL STANDARDS

Cayman Chemical supports preclinical drug

discovery and development by providing
high-purity psychedelic compounds and
custom synthesis. We are an ISO-accredited
source of controlled substances including
psilocybin, LSD, MDMA, and their
metabolites and derivatives.

LEARN MORE AT
CAYMANCHEM.COM/PSYCHEDELICS

BIOMEDICAL RESEARCH
PRODUCTS

CONTRACT
SERVICES

ANALYTICAL
STANDARDS

ACTIVE PHARMACEUTICAL
INGREDIENTS
 powered by

A 24-hour streaming program

For Health Care

Professionals,
By Health Care
Professionals
Season 6 is streaming now!
www.medicalworldnews.com
 4 8 5F US Highway One Sout h, Suite 2 10 | Iselin, NJ 08 8 30 | 609.7 16 .7 7 7 7

Michael J. Tessalone Megan L’Heureux

Senior Vice President, Group Editorial Director MANUSCRIPTS: To discuss possible article topics or obtain manu-
Industry Sciences MLheureux@mjhlifesciences.com script preparation guidelines, contact the group editorial director at:
MTessalone@ MLheureux@mjhlifesciences.com. Cannabis Science and Technology
Madeline Colli
mjhlifesciences.com welcomes unsolicited articles, manuscripts, photographs, illustra-
Editor
tions, and other materials but cannot be held responsible for their
Stephanie Shaffer MColli@mjhlifesciences.com
safekeeping or return. Every precaution is taken to ensure accuracy,
Group Publisher
Erin McEvoy but Cannabis Science and Technology cannot accept responsibility
SShaffer@mjhlifesciences.com
Assistant Editor for the accuracy of information supplied herein or for any opinion
Mark Davis EMcevoy@mjhlifesciences.com expressed.
Director of Sales
Alissa Marrapodi SUBSCRIPTIONS: For subscription and circulation information:
MDavis@mjhlifesciences.com
Custom Content Writer Cannabis Science and Technology, PO Box 457, Cranbury, NJ
Josh Crossney AMarrapodi@ 08512-0457, or e-mail mmhinfo@mmhgroup.com. Deliver y of
Director of Cannabis Events mjhlifesciences.com Cannabis Science and Technology outside the United States is
JCrossney@mjhlifesciences.com 14 days after printing.
Brianne Pangaro
Associate Marketing Director CHANGE OF ADDRESS: Send change of address to Cannabis Science
Edward Fantuzzi
BPangaro@mjhlifesciences.com and Technology, PO Box 457, Cranbury, NJ 08512-0457; alternately, send
Sales Director
EFantuzzi@mjhlifesciences.com Ariana Mexquititla change via e-mail to fulfill@mjhassoc.com or go to the following URL:
Graphic Designer http://mmhpubs.mmhgroup.com/Welcome.aspx?pubid=CNST
Oliver Waters
Sales Manager Marie Maresco Allow four to six weeks for change.
OWaters@mjhlifesciences.com Senior Art Director Cannabis Science and Technology (Print ISSN: 2643-8844, Digital
Liz McLean Melissa Feinen ISSN: 2643-8852) is published 9 times/year by MultiMedia
Sales Executive Creative Director, Publishing Healthcare LLC, 2 Clarke Drive, Suite 100, Cranbury, NJ 08512.
LMcLean@mjhlifesciences.com POSTMASTER: Please send address changes to CANNABIS
Alexa Rockenstein Science and Technology, PO Box 457, Cranbury, NJ 08512-0457.
Michael Kushner Permissions
Senior Director, Digital Media Return Undeliverable Canadian Addresses to: IMEX Global
MKushner@mjhlifesciences.com Solutions, P. O. Box 25542, London, ON N6C 6B2, CANADA.
corporate Canadian G.S.T. number: R-124213133RT001. Printed in the U.S.A.
Lindsay Gilardi President & CEO
Senior Virtual REPRINTS: Reprints of all articles in this issue and past issues of
Mike Hennessy Jr this publication are available (500 minimum). Licensing and Reuse of
Program Manager
LGilardi@mjhevents.com Chief Financial Officer Content: Contact Stephanie Shaffer about available usages, license fees,
Neil Glasser, CPA/CFE and artwork at SShaffer@mjhlifesciences.com for more information.
Anita Bali
Senior Project Manager Chief Operating Officer INTERNATIONAL LICENSING: Contact Alexa Rockenstein,
ABali@mjhlifesciences.com Michael Ball e-mail ARockenstein@mjhlifesciences.com.
© 2022 MultiMedia Pharma Sciences LLC All rights reserved. No part of this
Sabina Advani Chief Marketing Officer publication may be reproduced or transmitted in any form or by any means,
Senior Digital Brett Melillo electronic or mechanical including by photocopy, recording, or information
Production Specialist storage and retrieval without permission in writing from the publisher. Author-
SAdvani@mjhlifesciences.com Executive Vice President, ization to photocopy items for internal/educational or personal use, or the in-
Global Medical Affairs & ternal/educational or personal use of specific clients is granted by MultiMedia
Jeanne Linke Northrop Corporate Development Pharma Sciences LLC for libraries and other users registered with the Copy-
Managing Editor, Joe Petroziello right Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax
978-646-8700 or visit http://www.copyright.com online. For uses beyond
Special Projects
JLinke@clinicalcomm.com Senior Vice President, those listed above, please direct your written request to Permission Dept.
e-mail: ARockenstein@mjhlifesciences.com
Content
Megan Manzano Silas Inman MultiMedia Pharma Sciences LLC provides certain customer contact data
Senior Editor, (such as customer’s name, addresses, phone numbers, and e-mail addresses)
Special Projects Vice President, Human to third parties who wish to promote relevant products, services, and other
MManzano@mjhlifesciences.com Resources & Administration opportunities that may be of interest to you. If you do not want MultiMedia
Pharma Sciences LLC to make your contact information available to third par-
Shari Lundenberg
Stacy Argondizzo ties for marketing purposes, simply e-mail mmhinfo@mmhgroup.com and a
Vice President, Mergers customer service representative will assist you in removing your name from
Audience Development MultiMedia Pharma Sciences LLC lists.
SArgondizzo@ & Acquisitions
mjhlifesciences.com Chris Hennessy Cannabis Science and Technology does not verify any claims or other informa-
tion ­appearing in any of the advertisements contained in the publication, and
Executive Creative Director, cannot take responsibility for any losses or other damages incurred by readers
Creative Services in reliance of such content.
Jeff Brown To subscribe, e-mail mmhinfo@mmhgroup.com.

ycled P
Rec
INDUSTR
ABIS Y a
NN %
Chairman & Founder
AS
A

pe
NATIONAL C

50
SOC

r
10-20%
IATION

aste

Mike Hennessy Sr
rW

Po
s t C s u me
MEMBER on

4 Psychedelics: New Frontiers in Alternative Medicine  |    cannabissciencetech.com

 editorial advisory
board members cannabis science and technology®
m a y/ j u n e | v o l 5 • n o s 1

SUSAN AUDINO AUTUMN KARCEY PAUL LESSARD RICHARD SAMS

S.A.Audino & Associates, LLC Cultivo, Inc. Varin Science & KCA Laboratories
Engineering, LLC
DOUGLAS DUNCAN BENJAMIN A.KATCHMAN KEVIN SCHUG
PuEr Laboratory PathogenDx Inc. WILLIAM LEVINE Department of Chemistry &
CannRx Technology Inc. Biochemistry, The University
KATHERINE M. EVANS JULIE KOWALSKI
of Texas at Arlington
Longboard Scientific JA Kowalski Science ANTHONY MACHERONE
Consulting Company Support LLC Agilent Technologies, ANDRÉ FILIPE
Johns Hopkins University SANTARÉM SILVA
JACKLYN GREEN EBERHARDT KUHN
School of Medicine Merck
Agate Biosciences Shimadzu Scientific
Instruments DAVID L. NATHAN, MD, BRIAN SMITH
JACK HENION
DFAPA Big Sur Scientific
Henion Enterprises ALLEGRA LEGHISSA
Princeton Psychiatry
Department of Pharmacy, KATHERINE STENERSON
ZAC HILDENBRAND & Consulting, LLC
Hôpitaux Universitaires MilliporeSigma
Inform Environmental, LLC
Paris-Sud, AP-HP, Le JUMAR PASION
CHRISTIAN WEST
ADAM JACQUES Kremlin Bicêtre, France Principle Consultant
ZED Therapeutics
ZED Therapeutics

Cannabis Science and Technology ®’s Editorial Advisory Board is a group of distinguished individuals assembled to help the
publication fulfill its editorial mission to educate the legal cannabis industry about the science and technology of analytical
testing and quality control. With recognized expertise in a wide range of areas, board members perform various functions, such as
suggesting authors and topics for coverage, reviewing manuscripts, and providing the editor with general direction and feedback.
We are indebted to these individuals for their contributions to the publication and to the cannabis community as a whole.

Discover the latest cannabis medical research,

benefits, and treatment options
Introducing Cannabis Patient Care™
Cannabis Patient Care™ is the new resource for cannabis patients,
doctors, budtenders, dispensaries, and advocates to education
themselves on the benefits and treatment options cannabis provides.
Our mission is to help our readers on the path to wellness by
presenting cannabis as a viable treatment option.

Each of our issues focus on 6 core concepts: research, doctor, nurse,

patient, caregiver, and advocacy.

Visit our website to start your free digital subscription

CannaPatientCare.com

cannabissciencetech.com   
Psychedelics: New Frontiers in Alternative Medicine 5
 contents vol 5 • no s1
c a n n a b i s s c i e n c e a n d t e c h n o l o g y ®   |   m a y/j u n e 2 0 2 2   |  

8  
8
The Path to Legalized, Accessible
Psilocybin Therapy
L ARRY BERE SFORD
What would legalization and widespread availability of psilocybin
therapy look like? Here, we connect with Dr. Sunil Aggarwal, a
palliative care physician and cofounder of the Advanced Integrative
Medical Science Institute (AIMS) in Seattle, Washington, to find out.

12  
A New Clinical Trial in South Africa
Aims to Study the Effect of Psilocybin
on HIV Positive Women with Major
Depressive Disorder
ERIN MCE VOY
In this interview, Donaghue Woodman, Head of Research
and Development and Chief Medical Information Officer
at Cannsun, provides an in-depth look at their current
clinical trial on the effects of psilocybin in treating a
prevalent yet unresolved issue in South Africa. on the cover:
khamkula / adobestock.com

15   Anticipating Legalization: 25  
Cannabis and Psychedelics
Making Psilocybin Accessible Research: A Conversation
DE AN HARRIS
Here we present an outline of the areas that might with Dr. Denise Vidot
be critical in creating an infrastructure for building MEG AN L’HEUREUX
the right psilocybin production space. Dr. Denise C. Vidot, an epidemiologist at
the University of Miami and Founder of the
International Cannabis & Psychedelic Research
Collaborative, shares her research background,

19  
a short overview of her talk from this year’s
A Highly Contiguous Draft Reference Cannabis Science Conferences West titled,

Genome for the Psilocybe Cubensis “Co-Use of Cannabis and Psilocybin to Manage
Mental Health Amid the COVID-19 Pandemic:
Mushroom Is Now Available Preliminary Results from the International
FR ANK PRISC ARO COVID-19 Cannabis Health Study,” and more.
A brief summary of a new peer-reviewed paper detailing
the assembly of a highly contiguous draft reference genome
for the Psilocybe cubensis mushroom by Kevin McKernan,
Medicinal Genomics Chief Science Officer, and colleagues.

21  
Psilocybin Therapy for PTSD Follow us on social media for more updates
and Depression on the cannabis industry!
JA ME S SCHWART Z @CannabisScienceTechnology
@CannSciTech
An overview of the therapeutic role of psychedelics that
goes back thousands of years, as well as the new research
@CannabisSciTech @CannabisScienceTechnology
and the application of microdosing principles that have
6b9d44

created renewed interest in the power of psychedelics.

6b9d44

6 Psychedelics: New Frontiers in Alternative Medicine  cannabissciencetech.com

 from the editor
c a n n a b i s s c i e n c e a n d t e c h n o l o g y ®   |   m a y/j u n e 2 0 2 2   |  
Psychedelics: New Frontiers
in Alternative Medicine
WHAT COMES TO MIND when you hear psychedelics or
psilocybin? If you’re like me, perhaps you think of col-
lege-age kids experimenting with “magic mushrooms”
or funny scenes from movies such as Super Troopers.
What doesn’t immediately come to mind is the me-
dicinal use or microdosing of these substances. I first
started hearing about such things about a year or so
ago, still amid the global pandemic with lockdowns and
quarantines. People wanted to know if we were cover-
ing it—in fact, many people wanted us to cover it. I hes-
itated. I did not see the connection between psyche-
delics and cannabis, aside from the way the US Federal
Government classifies them. While I admit that I still
have much more to learn when it comes to psyche-
delics, I have discovered that the path for psychedelics
and cannabis to be seen as legalized medicine are per-
haps not too far from one another. Patients, advocates,
and researchers are paving the wave for psychedelics
to be viewed as a treatment option for certain indi-
cations in the same way that medical cannabis first
came about. The research and medical use surround-
ing psychedelics is growing—so, in this supplement, we
dive in to find out more from people in the field.
In our first article, Larry Beresford discusses what
legalization and widespread availability of psilocy-
bin therapy would look like with Dr. Sunil Aggarwal,
a palliative care physician and cofounder of the Ad-
vanced Integrative Medical Science Institute (AIMS)
in Seattle, Washington. Dr. Aggarwal already offers
ketamine-assisted therapy, which has shown power-
ful results against depression, suicidal ideation, and
psycho-spiritual distress.
In our next feature, Erin McEvoy interviews Dona-
ghue Woodman, the Head of Research and Develop-
ment and Chief Medical Information Officer at Cann-
sun. Cannsun was recently approved for a clinical
trial on the effects of psilocybin in treating a preva-
lent yet unresolved issue in South Africa. Their study
plans to look at the physical and mental health dis-
eases affecting a large population in South Africa by
cannabissciencetech.com
vol 5 • no s1
studying the effects of psilocybin with psychother-
apy on HIV positive women who have major depres-
sive disorder.
Once psychedelics are legalized in more states
(or countries), how do we make them more acces-
sible? Dean Harris presents an outline of the are-
as that might be critical in creating an infrastructure
for building the right kind of psilocybin production
space. We also have an exciting summary by Frank
Megan L’Heureux
Priscaro of a recently published peer-reviewed pa-
per detailing the assembly of a highly contiguous Group Editorial
draft reference genome for the Psilocybe cuben- Director,
Cannabis Science
sis mushroom written by Kevin McKernan, Medicinal and Technology ®;
Cannabis
Genomics Chief Science Officer, and colleagues. Patient Care ™
In another paper, nurse James Schwartz provides
an overview of the therapeutic role of psychedelics mlheureux@
mjhlifesciences.
that goes back thousands of years, as well as the com
new research and the application of micro-dosing
principles that have created renewed interest in the
power of psychedelics. And last, but certainly not
least, we present a conversation with Dr. Denise C.
Vidot, an epidemiologist at the University of Miami
and Founder of the International Cannabis & Psy-
chedelic Research Collaborative. Dr. Vidot shares her
research background, a short overview of her talk
from this year's Cannabis Science Conference West
titled, “Co-Use of Cannabis and Psilocybin to Manage
Mental Health Amid the COVID-19 Pandemic: Prelimi-
nary Results from the International COVID-19 Canna-
bis Health Study,” and more.
I hope you’ll join us in learning more about psych-
edelics and the fascinating work that is being done
to understand how to use them as a medicine. Enjoy!
 
Psychedelics: New Frontiers in Alternative Medicine 7
feature
The Path to Legalized,
Accessible Psilocybin Therapy
BY L A R RY B E R E S F O R D
S
MALL-SCALE PUBLISHED STUDIES have
shown dramatic results for psilocybin as a treat-
ment for the depression and demoralization ex-
perienced by people confronting a terminal or
life-threatening illness, among other mental health appli-
cations. Numerous parties are asking how this psychedelic
substance could become recognized, permitted, and wide-
ly accessible for treatment uses beyond its current, limited
research context. But the legal barriers, primarily at the US
Federal Drug Enforcement Administration (DEA), contin-
ue to impede these wider applications.
Research teams at New York University (NYU) Lan-
gone Health (New York, New York), Johns Hopkins Med-
ical Center (Baltimore, Maryland), and elsewhere contin-
ue to advance our scientific understanding of psilocybin,
a psychedelic drug derived from so-called “magic” mush-
rooms, for the treatment of spiritual and existential
8 Psychedelics: New Frontiers in Alternative Medicine   
|  vol. 5 no. 5 cannabissciencetech.com
suffering and trauma. Meanwhile, pharmaceutical com-
panies wait in the wings, in anticipation of its legalization
within the next few years.
But what would legalization and widespread availabili-
ty of psilocybin therapy look like? Sunil Aggarwal, MD, a
palliative care physician and cofounder of the Advanced
Integrative Medical Science Institute (AIMS) in Seat-
tle, Washington, wants to find out. AIMS provides what
it calls “entheogen”-assisted psychotherapy with psy-
Image credit: Oleksandr/ adobe.stock.com
choactive substances that have historically been used for
culturally sanctioned mystical or visionary experiences.
Dr. Aggarwal already offers ketamine-assisted therapy, us-
ing that legally available psychedelic and Federal Drug Ad-
ministration (FDA)-approved anesthetic, which has shown
powerful results against depression, suicidal ideation, and psy-
cho-spiritual distress. Its effects are said to resemble a near
death experience. “I’ve been using ketamine-assisted therapy

in my practice for almost five years to help
people with severe, crushing, existential
anxiety,” said Dr. Aggarwal.
Dr. Aggarwal and two of his ketamine
therapy patients are party to a lawsuit
against the DEA seeking legal authori-
zation to provide psilocybin under state
and federal right-to-try laws designed
to allow humane access to drugs that
are still under clinical investigation.
An Emerging
Palliative Care Leader
In 2020, Dr. Aggarwal was named
an Emerging Leader in Hospice and
Palliative Care by the American Acade-
my of Hospice and Palliative Medicine
(AAHPM). AAHPM is the professional
society that represents doctors who are
medical board-certified in the specialty
of hospice and palliative medicine, along
with other health professionals who work
in palliative care—a field that focuses on
relieving pain and suffering and helping
patients with serious illness to articulate
and achieve their treatment preferences
and goals for medical care.
He was an inaugural member of AAH-
PM’s 360-member Safe Use of Psyche-
delic-Assisted Therapies Forum, and he
recently presented an online master prac-
titioner class titled, “How Psychedelics
Can Be Used for Relief of Spiritual and
Existential Suffering,” for 348 registered
professionals at the Center to Advance
Palliative Care in New York, New York.
“I’ve also had my own personal expe-
riences with these substances as a college
student, discovering that they could offer
valuable insights into human conscious-
ness. That helped impel me on my path to-
ward becoming a doctor,” said Dr. Aggar-
wal. He also has a BA in philosophy and
chemistry, with a religious studies minor
from the University of California, Berke-
ley, and a PhD in medical geography from
the University of Washington.
He sees growing interest in psyche-
delics by both health care profession-
als and consumers. “We need to listen
cannabissciencetech.com
psilocybin therapy /  feature
to our patients. They don’t only want Bob Stanley
a clinical experience, but a ceremoni-
al one, with entheogenic medications
such as psilocybin.”
What Is Going on Here?
For many experienced medical profession-
als, psychedelic therapy to help termi-
nally ill patients cope with the negative
feelings that accompany their prognosis
must seem like quite a stretch—despite
the tantalizing outcomes to date from
non-randomized studies of psilocybin
therapy. Patients who receive just one or Kathryn Tucker
two therapist-accompanied treatments
with post-treatment follow-up sessions
to integrate what they experienced from
the drug, report immediate and sustained
relief of their debilitating anxiety and
depression and improved psychological,
spiritual, and existential well-being.
“We believe these substances can be
neuroplastic, which refers to the ability
of the brain and neurological system to
develop more new linkages and connec- Dr. Sunil Aggarwal
tions between different neurons,” Dr.
Aggarwal explained. “When you have
new connections and can build new
neuropathways, you can think about
things in new ways—which is impor-
tant if you have gotten stuck mentally.”
Some might also say the healing re-
sults from a mystical or spiritual en-
counter, but Dr. Aggarwal does not have
a clear answer. “It’s nothing I can even
explain. It’s a conscious transformation
in the person’s life. It’s an existential in-
sight that changes their life—helping good candidate, the interdisciplinary
them let go of a lot of things,” he said. palliative care team starts the prep
How would this healing work in ther- work: clarifying therapeutic intentions
apeutic practice? “Assuming that we had and what the patient is hoping for. The
licensure to purchase and dispense psil- person who will be sitting with the pa-
ocybin, patients would sign an informed tient on their psychedelic journey can
consent, and then undergo a medical and start to build a relationship with them.
psychological screening,” he said. That’s Psilocybin administration then hap-
to make sure there are no underlying pens in a comfortable, peaceful, well-ap-
cardiac conditions, drug-drug interac- pointed room, with offers of music, an-
tion concerns, or other psychological or ti-nausea medications, and non-directive
medical impediments to the treatment. support. “That’s similar to how we now
Once it is clear that the patient is a give ketamine, although the psilocybin
   
|   Psychedelics: New Frontiers in Alternative Medicine 9
feature / psilocybin therapy
session would last five to six hours, rath-
er than just two to three hours for keta-
mine,” Dr. Aggarwal explained.
How to Get There from Here
Dr. Aggarwal said he is looking for any
potential solutions that would permit
offering this option to his patients,
including the right-to-try suit. “We
found producers willing to provide the
psilocybin to us. The state pharmacy
commissioner also signed off—so long
as the DEA says it’s okay,” he stated.
Others who have submitted amicus briefs
in support of Dr. Aggarwal’s suit include
attorney generals from Washington and
several other states, the American Civil
Liberties Union (ACLU), and two former
presidents of AAHPM.
“Palliative care providers are eager to
add these tools to their armamentariums
for relieving suffering,” said Dr. Aggarwal’s
lawyer, Kathryn Tucker, a patient rights ad-
vocate, and Special Counsel with Emerge
Law Group. “Nobody wants to imagine a
terminally-ill patient left in unrelieved suf-
fering when we know there’s a tool that
could bring relief to countless patients.”
Psilocybin is an investigational drug
that has completed Phase I trials test-
ing its safety and remains under investi-
gation. “This drug qualifies under feder-
al and state right-to-try laws, which were
intended to allow seriously ill patients to
access certain investigational drugs for
therapeutic use,” said Tucker. “But the
DEA has refused to open that avenue to
access. We are in a major effort to open
that door, and we are committed to pur-
suing it until successful.”
When the DEA declined Dr. Aggarwal’s
request to permit access to psilocybin for
treatment, Tucker brought suit with two
of his cancer patients to the Federal Ninth
Circuit Court of Appeals in San Francis-
co, California, which heard arguments in
September 2021. At the end of January
2022, the court turned down the suit on
the grounds that the DEA’s ruling did not
constitute a final judgment. Tucker’s team
10 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no. 5 cannabissciencetech.com
brought the case back to the DEA for final
determination regarding right-to-try ac-
cess and filed a petition to reclassify psilo-
cybin from Schedule I to Schedule II.
“In the event of continued delays, we’ll
bring a mandamus action to try to get the
court to intervene, because our clients do
not have the time to withstand continued
delay,” she added. In 2020, Oregon enact-
ed the nation’s first state law to legalize
access to psilocybin and a number of mu-
nicipalities have also decriminalized the
drug. But these efforts must still contend
with federal law enforcement. The legal
team has also reached out to members of
Congress for their help.
The Spiritual Path
For Dr. Aggarwal, it is important that the
administration of psilocybin happens in a
wider context of preparation, accompani-
ment, and post-treatment integration of
the experience with a trained therapist.
He hopes all of these services could be
covered by health insurance.
But he is also inspired by the religious
groups that have sprung up with a spe-
cial mission to offer psychedelic expe-
rience as religious ritual, and in all the
cross-cultural mixing of different tradi-
tions surrounding psilocybin and other
entheogens. Freedom-of-religion guar-
antees make it possible for such groups
to legally offer psychedelics as a sacra-
ment. An example is the Sacred Garden
Community in Oakland, California (1).
“It might make sense to refer clients
like mine who want to pursue psilocybin
through such churches, just as palliative
care refers patients to chaplains and oth-
er religious leaders in the community,”
said Dr. Aggarwal. Patients could con-
tact the church and start to do their own
preparation, but palliative care could
still be part of their preparation or inte-
gration. “That could be easier until we
get larger solutions.”
Bob Stanley, co-founder, Senior Gar-
den Steward and pastor for Sacred Gar-
den, says his church wants to avoid being
misunderstood about psychedelic sub-
stances, which it recognizes as sacra-
ments and believes are covered under
protections for religious freedom. But
they take that responsibility very seri-
ously. They want to learn from the sec-
ular world and from its clinical and psy-
chological insights, such as how to be
safe with entheogens. “But this is a
church. We engage these sacraments
from a commitment to care, respect and
integrity in relationship, offering faith-
based community for preparation, cer-
emony, and integration of what can be
deeply divine experiences. This is a sa-
cred practice for us,” said Stanley.
“Our goal is not to become some kind
of legal workaround for medical provid-
ers to allow for the therapeutic provision
of psychedelics to their patients. We offer
pastoral counseling,” Stanley explained.
“Every member of our church is open to
the possibility of direct experience of the
divine, whether that is called God, satori,
or by other names. We believe the sacra-
ments of our church can make the divine
accessible in this lifetime.”
In particular, his group sees the end of
life as a sacred time, with a distinct liturgy
for the dying. “With the experience of the
divine we believe we can have in this life,
it’s not just a pill you take and go there. It’s
about intention and asking,” he says. “It’s
not a clinical experience.”
In the meantime, Dr. Aggarwal, his law-
yers, and others will continue to push for
legalized therapeutic access to psyche-
delics like psilocybin, among other enthe-
ogens that have attracted interest world-
wide. The impressive, though preliminary
and small-scale, results to date on the ben-
efits of psilocybin, in particular, would
seem to demand nothing less.
Reference
(1) https://sacredgarden.life.
About the Author
LARRY BERESFORD is a freelance writer
based in California. Direct correspondence to:
larryberesford@hotmail.com
 Human Capital Advisement +
Executive Search Partner for the
Cannabis & Psychedelics Industries

HUNTER + ESQUIRE is the premier retained executive search and human capital advisory
firm specialized solely in the cannabis and psychedelics industries
.
Founded in 2017, our experienced team is dedicated to providing a customized,
full-service, white-glove approach to every one of our clients.

Our deep industry expertise, in combination with decades of talent acquisition

experience and advisement, makes us an integral and trusted partner to the most
aspirational cannabis and psychedelics companies looking to establish themselves as
leaders in these burgeoning markets.

We believe in the “inch wide / mile deep” philosophy and offer our clients a consultative
approach to business strategy and executive recruitment rooted in deep expertise and a
world-class network.

Hunter + Esquire helps cannabis and psychedelics organizations break through the
unique and complex challenges facing each industry.

When you partner with Hunter + Esquire, you work with dedicated and experienced
professionals who are committed to elevating your organization.

Contact Us Today to Learn More

HUNTER + ESQUIRE
www.hunteresquire.com/
hello@hunteresquire.com
feature

A New Clinical Trial

in South Africa Aims
to Study the Effect of Psilocybin on HIV Positive
Women with Major Depressive Disorder
BY E R I N M C E VOY

With an increased interest in the medical uses of psychedelics, new studies are emerging
to explore their potential to treat mental health illnesses. One company, Cannsun
Medicinal Global, is looking to address physical and mental health diseases affecting a
large population in South Africa by studying the effects of psilocybin with psychotherapy
on HIV positive women who have major depressive disorder (MDD). Cannsun is a
Image credit: contentdealer/ adobe.stock.com

biopharmaceutical company that develops and commercializes new medicines, with a

focus on research and development in both women’s health and mental health. In this
interview, Donaghue Woodman, Head of Research and Development and Chief Medical
Information Officer at Cannsun, provides an in-depth look at their current clinical trial on
the effects of psilocybin in treating a prevalent yet unresolved issue in South Africa (1).

12 Psychedelics: New Frontiers in Alternative Medicine  |    cannabissciencetech.com


Can you tell us more about
Q: your work at Cannsun
Group PLC?
Donaghue Woodman: As
A: Head of Research and Develop-
ment, I’m responsible for investigating
and initiating novel active pharmaceu-
tical ingredients (APIs), research, and
trials, respectively, that will make a
positive lasting change on diseases
that impact populations, especially
women, within developing countries. I
assist in navigation of the regulatory
environment to ensure that we not
only remain compliant, but also
contribute to new laws and regulations
around cannabis and psychedelic
therapies in southern Africa.
As Chief Medical Information Of-
ficer of CannhealthMD, Cannsun’s
Clinical Education arm, I am respon-
sible for data analysis on current med-
ical needs and market gaps relating to
medical cannabis and psychedelics; the
creation of educational content and
forums; training of medical doctors,
nurses, and pharmacist on medical
cannabis and psychedelics in South Af-
rica; and lastly forming valuable part-
nerships and collaborations for ver-
tical integration of our operations in
sub-Saharan Africa.
What prompted Cannsun
to conduct a study on
Q: the effects of psilocybin
on major depressive
disorder (MDD)?
Woodman: Major depressive
A: disorder (MDD) impacts more
than 300 million people globally and has
led to rising healthcare expenditures in
both private and public sectors. Mental
health conditions such as depression
and anxiety cost the South African
economy more than $12.5 billion
because of mental ill health. Patients
suffering from MDD are at higher risk of
cannabissciencetech.com
clinical trial /  feature
mortality than those who aren’t; in
sub-Saharan Africa, where an estimated
8.2 million people are living with HIV,
MDD is one of the more prevalent
co-morbidities in human immunodefi-
ciency virus (HIV) and in women. Data
presented by the South African College
of Applied Psychology in 2018 (2)
suggest that one in six South Africans
suffers from anxiety, depression, or a
substance use disorder. According to the
data, 40% of South Africans living with
HIV have a comorbid mental disorder,
41% of pregnant women are depressed,
and about 60% of South Africans could
be suffering from post-traumatic stress.
Due to the high rate of relapse, which
could be as much as 40-60%, new
therapies and treatment modalities are
urgently needed.
Can you share more details
about the clinical trial?
Q: What are you hoping
to learn?
Woodman: The trial is a
A: double-blind, randomized,
phase 2 feasibility study of psilocy-
bin-assisted brief supportive psycho-
therapy in an HIV positive all female
group with major depressive disorder.
The trial will comprise of 30 partici-
pants and each participant will be
inducted into the trial for three
months in total. The trial will be
conducted at TASK facilities in Cape
Town, South Africa.
The aim of the study is not only to
assess safety and efficacy of psilocy-
bin in HIV positive individuals, but to
also assess the entourage effect of es-
trogen and psilocybin in treatment of
MDD in women.
Why is it important that
the participants in this
Q: study are both women
and HIV positive?
Psychedelics: New Frontiers in Alternative Medicine
Woodman: Women are twice
A: as likely to contract HIV than
men in sub-Saharan Africa. In these
regions, women between the ages of
15–19 years account for 6 in 7 new HIV
infections, contributing to 63% of all
new infections. In 2020, an estimated
4200 women between the ages of 15–24
years became infected weekly. Serious
mental illness is associated with
harder-to-treat progression of HIV
disease. Depression has been associat-
ed with lack of medication adherence
among HIV positive infected individu-
als. Treatment with antidepressant
medication has shown to assist in
improving antiretroviral adherence
among those suffering from mental
health issues. Comorbid psychiatric
diseases linked to HIV, such as major
depressive disorder and substance
abuse, have been shown to be predic-
tive precursors of suicidal ideation in
HIV positive individuals. A recent study
conducted in HIV positive individuals
discovered that persons with a history
of suicidal ideation reported signifi-
cantly higher degrees of current
depressive symptoms and had a greater
13
feature / clinical trial
prevalence of not only major depressive
disorder but showed higher levels of
plasma HIV RNA (3).
Women have previously been un-
der-represented in clinical trials relat-
ed to mental health, and in trials where
women were included, the published
results were not always gender specif-
ic. In addition, post puberty, women
have a 2:1 increased prevalence of ma-
jor depression compared to men. Cur-
rent treatment for depression is subop-
timal or ineffective in approximately
50% of patients.
It is vitally important to have a
deeper understanding of how wom-
en respond to medical treatment for
major depression versus men in order
to develop psychedelic therapies and
treatment protocols for women that
have clinically significant outcomes
that are safe and effective.
Can you tell us about the
partnerships you have formed
Q: for conducting this study, such
as with TASK and with
Professor Soraya Seedat?
Woodman: Established in
A: 2005, TASK is a renowned
research specialist organization in
infectious diseases, most notably in
tuberculosis (TB), COVID-19 treat-
ment, and vaccines. TASK’s founder,
Professor Andreas Diacon, has been
celebrated by the Bill and Melinda
Gates Foundation as a “hero in the
field” for his contribution to TB
drug development.
The TASK clinical research organi-
zation (CRO) will work in conjunction
with Soraya Seedat, a distinguished
Professor of Psychiatry and Executive
Head of the Department of Psychiatry
at Stellenbosch University in South
Africa. She has more than 20 years of
clinical, epidemiological, and basic
14 Psychedelics: New Frontiers in Alternative Medicine
neuroscience research experience as
a psychiatrist. She has also been the
recipient of several awards includ-
ing the World Federation of the Socie-
ty of Biological Psychiatry Fellowship,
the Anxiety Disorders Association of
America Career Development Award,
the Humboldt Research Award, and
many others.
When do you hope to have
Q: results published?
Woodman: Each patient will
A: be enlisted into the trial for at
least three months, and due to the
high rate of HIV in South Africa and
emphasis being placed on mental
health and major depressive disorder,
we foresee trial completion in about
eight months from our start date in
July. The results of the trial will most
likely be published by April or May
2023 by Professor Seedat from USB
post completion.
What have other studies
suggested so far about
Q: the effect of psilocybin
on treating mental
health conditions?
Woodman: A recent study
A: published by Roland Griffiths
and colleagues (2022) examining the
safety and efficacy of psilocybin over a
12 month period in a patient group
suffering from moderate to severe
MDD showed that the substantial
antidepressant effects of psilocybin-as-
sisted therapy may last 12 months
following acute intervention in certain
patients (4). This data serves as a
valuable tool for future research and
development and government planning
of mental healthcare policies and
healthcare expenditure in combating
major depression in countries like
South Africa.
What sorts of research has
Cannsun conducted with
cannabis? Have you conduct-
Q: ed any studies on the use of
cannabis as a treatment in
conjunction with psilocybin?
Woodman: Cannsun Group
A: PLC, founded by David Parry
and managed by our Canadian-based
COO Aaron Katerenchuk, is a
bio-pharmaceutical company focused
on developing and commercializing
new medicines to optimize human
potential with operations in South
Africa and Thailand. Cannsun
Medicinal Global has a strong focus on
research and development in both
women’s health and mental health. We
are in the process of finalizing a
clinical trial proposal for submission
to the regulatory authority for
research in schizophrenia (phase 1
trial). No combination therapy trial
using both cannabis and psilocybin as
a treatment modality has been done in
South Africa to date due to the
sensitive nature of these molecules in
South Africa and their regulatory
status. Although Cannsun has been
awarded the first psilocybin trial and
is cultivating medicinal cannabis in
Atlantis, South Africa both of these
modalities are still classed under a
Schedule 7 substance in terms of the
Medicines and Related Substances Act
101 of 1965.
Where do you hope
Q: to see more research
in the future?
Woodman: I wish to see
A: more research done on and
documented scientific data present-
ed on whole psilocybin mushroom
extract used to treat mental health
disorders versus single molecule API.
I wish to see more integrative
CONTINUED ON PAGE 18
cannabissciencetech.com

Anticipating
Legalization:
Making Psilocybin Accessible
BY D E A N H A R R I S
A
S SOMEONE WHO remembers the
psychedelic times of the 1960s, psych-
edelics such as psilocybin have come
a long way from Dr. Timothy Leary’s
mantra of “turn on, tune in, and drop out.” Today,
psilocybin is being studied seriously for therapeu-
tic applications at top medical schools, often with
the support of the US government.
For example, the study of psilocybin to help
advance mental wellness is being conducted at
Johns Hopkins Medical School (depression, anxi-
ety, smoking cessation); Yale University is doing a
study on major depressive disorder; Harvard Uni-
versity is studying clinical depression; the Univer-
sity of Texas at Austin is studying depression and
anxiety); and New York University is studying sub-
stance abuse and PTSD (1–5). This is by no means
a comprehensive list. Important research on psil-
ocybin is taking place now at many universities
throughout the world.
This increase of research activity also coincides
with an increasing shift towards the legalization or
decriminalization of psilocybin both inside and out-
side of the US. Legalization typically considers four
primary touch points: possession, sale, transport,
and cultivation. These factors vary by locality and
are changing so frequently that listing them here
Image credit: contentdealer/ adobe.stock.com
will render them out of date from the time this pa-
per was written until the time it is published. That
being said, legal psilocybin probably is coming soon
cannabissciencetech.com
feature
to a market near you. Think of how quickly canna-
bis became legal once a few states passed legisla-
tion. With so many benefits of psilocybin being re-
searched, one can assume that the legalization of
psilocybin should happen even faster. It is logical to
envision states and indeed countries where psilo-
cybin sales and even psilocybin tourism becomes a
significant part of the local economy.
Once psilocybin is accepted legally and med-
ically for wellness programs, it’s then important
to consider where it will be cultivated, how it will
be processed, and in what forms it will be offered.
Currently, most psilocybin is available on the black
or grey markets. With a lack of oversight and regu-
latory guidance, consumers have little to no trans-
parency into what they are using, its origin, and
how it is processed. Proper dosage is also a major
question mark in the space as consumers wonder
how much they are taking and how much psilocy-
bin they should take. This dosage question is es-
sential because given a positive or negative experi-
ence with psilocybin, consumers will want to know
how much they have used.
Since psilocybin is in the early stages of legal
commercialization on a production-level scale,
there is a unique opportunity to establish the prod-
uct ecosystem carefully and correctly. Fundamen-
tal to any attempt to create markets for a prod-
uct is an understanding what consumers want.
That is the very definition of marketing. Given this
   
|   Psychedelics: New Frontiers in Alternative Medicine 15
feature / processing/manufacturing
orientation, our team is focused on deliv-
ering six key benefits for our psilocybin
offerings:
1. Convenience: The product should
be convenient to use, convenient
to buy, convenient to carry, and
convenient to store.
2. A ssured dosing: The product
should be delivered in an as-
sured dose including a microdose
option. Currently, consumers
have little idea as to what dose
they require or what dose they
are taking. Reliable dosing helps
insure a consistent and positive
experience.
3. Bioavailability: Consumers prefer
a functional product and a faster
onset time via improved bioavail-
ability, which makes the prod-
uct more functional and far more
appealing.
4. Safety: Consumers want to know
that what they are ingesting is
safe. That’s why comprehensive,
independent third-party labora-
tory testing for purity and poten-
cy on every batch is important
for widespread adoption.
5. Palatability: The product should
taste and smell good. Since
mushrooms typically do not have
great flavor or aroma, a better
tasting product with a better aro-
ma will improve the customer ex-
perience markedly and will deliv-
er more sales.
6. Affordability: Making the product
affordable extends the market to
a larger addressable and acces-
sible audience. Quite simply, that
means more consumer trial and
adoption plus greater sales. Af-
fordability will make it easier for
people to integrate psilocybin
into their daily lives. This means
frequency of usage, an objective
16 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no. 5 cannabissciencetech.com
that any repeat purchase product
is seeking.
In Oregon, we are developing a spore-
to-sale model for psilocybin, mindful of
our goals of providing our six core ben-
efits. Here is an outline of the areas we
believe are critical in creating an infra-
structure for building the space right.
Our intent is to develop a lightweight,
non-capital-intensive, portable mod-
el that is replicable globally as psilocy-
bin becomes legal from state to state and
from country to country.
Legal, Regulatory,
and Compliance
It is essential to create a psilocybin
product within the legal and regulatory
environment of the states and countries
in which we plan to operate. Laws and
regulations do vary by jurisdiction, so it
is essential to find legal experts in that
jurisdiction. Fortunately, there are indi-
vidual lawyers and law firms well-versed
in psychedelics law that can help. Some
attorneys who operate within this special-
ty do cover multiple jurisdictions. Others
will only cover one jurisdiction. Our plan
is to interview extensively and then hire
exceptional lawyers before proceeding to
build in any place we expect to operate.
Genetics
The right genetics will be essential to
create unique, high-quality psilocybin
offerings. We have access to a library of
psilocybe cubensis sub-species curated
from unique regions throughout the
world. Most of the strains are 7th genera-
tion with low heterozygosity (or genetic
deviation). These genetics have been
stored carefully using swab prints, slants,
and petri dishes. This premium library
contains many high yielding strains that
have been isolated for strength, resis-
tance to contamination, and psilocybin
or psilocin potency. Many of our genetics
also maintain fast colonization rates over
multiple flushes.
Culture Maintenance Set-Up
and Lifecycle Management
Setting up a functional laboratory environ-
ment that controls plating and cultivation
is a challenging task. The laboratory set-up
must consider state regulated compliance,
building codes, and many approvals, most
likely from multiple government agencies.
Once these hurdles have been cleared, set-
ting up a proper laboratory environment
requires the following:
Lifestyle Architecture
This must involve well planned proce-
dures for spore transfers to agar plates
for isolations, as well as mycelium to live
culture growth transfers. There must be
long-term storage plans and capabilities
to maintain proper genetic health. In
addition, appropriate infrastructure must
be designed and built to house, maintain,
and ensure non-contamination in near
zero temperatures. Specialized cryogenic
expertise is a necessity. Humidity must
be controlled as well and processing
systems must have minimal touch time
to avoid unwanted exposure risks.
Isolation Procedures
Strict isolation procedures are critical
to a high quality and consistent result.
They include:
•A  gar core to agar plate
• Agar core sample to live culture
•S  pore printing to glass, fill, and swab
• T issue sampling to live culture and
cryogenic storage
Sterilization and
Pasteurization Procedures
One cannot ignore the importance of
sterilization and pasteurization. These
procedures are vital:
• L ive culture isolation
•S  pawn media

•C  hoosing the correct substrate me-
dia prior to pasteurization
• T he proper selection of tools and
equipment is essential to complete
these tasks
Inoculation Procedures
The second phase of inoculation proce-
dures includes work in:
• L ive culture to spawn media
•S  pawn media to spawn media
(grain to grain)
•S  pawn media to substrate
Fruiting Chambers
Next is the selection and build-out of
the fruiting chambers. This includes the
design and the preparation of the vessels
as well as the application of proper steril-
ization procedures. Once the chamber is
in place, additional procedures must be
formalized. This includes:
•C
 olonization protocols
•E
 nvironmental controls
•A
 ir exchange
•H
 umidly control
Spawn Media and Substrate
Media Preparation
Critical spawn media procedures
include:
•S
 oak and rinse
•P
 re-sterilization
•P
 asteurization and sterilization
Substrate media procedures include:
•C
 reating a media ratio with specif-
ic considerations towards sub spe-
cies preferences
•M
 edia blending and safe handling
protocols
Harvesting, Drying, and Storage
Now that the psilocybin has been
grown, it’s time to harvest in equally
controlled conditions.
This requires cleaning, handling,
and harvesting techniques built to the
strictest standards. Of course, drying
cannabissciencetech.com june 2022  |
processing/manufacturing /  feature
and storage is important too as
we consider:
•P  roper handling to help eliminate
contamination
•H  umidity-controlled drying
• F reeze-drying for improved efficacy
of the finished fungi
•A  lkaloid preservation techniques
• T echniques that enhance
long-term storage
Extraction
For psilocybin, we favor full plant ex-
traction, which more closely resembles
grinding over traditional extraction
techniques such as CO2 extraction.
This process supports the preservation
of active constituents that captures a
fuller experience from fungi biology.
Formatting into Powder
and Tablets
Our company has developed a pat-
ent-pending process where we can turn
fungi-derived active ingredients into
a good tasting, water-soluble tablet,
sublingual tablet, or single serving pow-
der dose. The effervescent tablets and
powder forms mix quickly and evenly in
any hot or cold liquid. In addition, we re-
cently developed a sublingual tablet form
that dissolves discretely under the tongue
without having to drink any liquid. This
tablet is highly bioavailable and comes in
a pleasant mango or mint taste. Both the
tablet and powder forms provide a more
convenient, better tasting way of using
psilocybin. These forms also feature
accurate dosing and a faster onset time
due to enhanced bioavailability.
Analytical and
Regulatory Testing
Similar to cannabis testing, potency lev-
els and contamination levels play an im-
portant part in psilocybin testing. While
few standard psilocybin testing methods
exist in the US, we want to be at the fore-
front of delivering consistent protocols.
Psychedelics: New Frontiers in Alternative Medicine
This requires a prescriptive approach to
testing protocols, equipment, chemical
concentrations, and much more. As
analytical and research laboratories begin
entering the space in great numbers, it’s
also important to ensure accuracy and
data integrity. Importantly, there must be
agreed upon and detailed methods used
universally across the space. This model
is not unique as it has been used in other
industries that have been successful in
delivering safe, contamination-free, and
high-quality products people consume
with confidence.
As the psilocybin landscape matures,
regulatory laboratories will be required to
hone and perfect DNA and genetic test-
ing protocols. For example, Oregon is re-
quiring the use of Psilocibe cubensis. This
requires the proper extraction of actives
without denaturing or inhibiting quantifi-
cation of psychoactive compounds.
While laboratories will be focused on
regulatory standards, it is clear that more
research is required. This research may
come from medicinal mushroom compa-
nies in the nutraceutical and supplement
space who are seeking similar testing ca-
pabilities as well as new markets. This will
add to the support and sophistication of
testing for fungi, in both psychedelic and
non-psychedelic varieties.
Research
Today’s regulatory models address
the value stream and production of
psilocybin. Currently, much of the
psilocybin research is being conduct-
ed in academic settings with little
emphasis on commercialization. We
believe research should address a fuller
ecosystem. This can include genet-
ics, strain management, processing
improvements, post processing, and
clinical applications. The involvement
of the private industry in this research
will take what is learned in all settings
and apply this learning to help build
superior products.
17
feature / processing/manufacturing
Mass Production
Our objective is to develop a pro-
duction facility model that can work
across borders and in low, medium,
and high output settings. We want to
model facilities that are neither space
nor power intensive. Our additional
goal is to utilize and provide effective,
commonly available equipment that
can be sourced anywhere in the world
new, used, or on a leased-basis. This
supports our goal of model portability
and product affordability.
Marketing and
Communications
Too often, marketing and communi-
cations is an afterthought in psyche-
delics. That’s a mistake we will not
make. We are actively involved in
CONTINUED FROM PAGE 14
holistic research done on schizophre-
nia to reframe and redefine the so-
called disease in context of western
versus traditional views and how
schizophrenia relates to psychedelics.
I wish to see the documented use and
efficacy of ayuasca in schizophrenia.
Lastly, I would like to see addition-
al research and publication of more
scientific data of African psychedelic
iboga in treatment of substance abuse
disorders.
Is there anything else you’d
Q:
like to add?
Woodman: For psychedelic
A: therapy to be a success and
“re-integrate” its way into medicine and
18 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no. 5 cannabissciencetech.com
creating product narratives that will
resonate well in the earned, owned,
and paid media spaces.
Conclusion
In summary, we believe we have
outlined a sophisticated, efficacious,
yet highly portable model that can be
transferred across states and country
borders. Given adherence to this model
the goal of producing convenient, accu-
rately dosed, highly bioavailable, safe,
good tasting, and affordable psilocybin
is achievable. We are excited about the
prospect of building this valuable and
important market with high standards,
sound thinking, and care.
References
(1) h ttps://news.yale.edu/2021/07/05/
society, more focus needs to be given to
finding cost efficient ways of manufac-
turing psychedelic therapies to provide
equal affordable access to all. Psyche-
delic use among African people,
including for mental health, needs to be
destigmatized globally through
awareness and education. More empha-
sis needs to be placed on set and
setting, and on setting up global
training centers for specialists who
wish to administer psychedelic
therapies. Pharmaceutical organiza-
tions will need to collaborate closely
with government institutions, regulato-
ry authorities, research organizations,
leading experts, and universities to
ensure that the education, incorpora-
psychedelic-spurs-growth-neural-
connections-lost-depression.
(2) h ttps://www.hopkinsmedicine.org/psychiatry/
research/psychedelics-research.html.
(3) h ttps://news.harvard.edu/gazette/
story/2021/06/harvard-medical-school-
professor-discusses-future-of-psychedelics/.
(4) h ttps://dellmed.utexas.edu/news/dell-med-
launches-center-to-study-psychedelics-for-
treatment-of-depression-anxiety-ptsd.
(5) h ttps://med.nyu.edu/departments-institutes/
population-health/divisions-sections-
centers/medical-ethics/education/
high-school-bioethics-project/learning-
scenarios/ptsd-treatment-psychedelics.
about the author
DEAN HARRIS is the CEO of TabBrands.
Direct correspondence to:
dean@tabbrands.com
tion, ethical use, and accessibility of
psychedelic medicines into a country
will benefit its people in both private
and public setting and that the
necessary infrastructures are in place to
support both patients and healthcare
providers alike.
References
(1) h ttps://www.newswire.com/news/
cannsun-receives-approval-for-the-first-
womens-focused-phase-ii-21683642.
(2) h ttps://journals.sagepub.com/doi/fu
ll/10.1177/00812463211001543.
(3) h ttps://www.ncbi.nlm.nih.gov/
pmc/articles/PMC4966661/.
(4) h ttps://pubmed.ncbi.nlm.nih.gov/35166158/.
 feature
Image credit: Alexander/ adobe.stock.com

cannabissciencetech.com october 2021  |   Psychedelics: New Frontiers in Alternative Medicine 19

feature / lab & facilities
A Highly Contiguous Draft
Reference Genome for the
Psilocybe Cubensis Mushroom Is Now Available
Kevin McKernan, Medicinal Genomics Chief Science Officer, is the principal author of a new peer-reviewed paper (1)
detailing the assembly of a highly contiguous draft reference genome for the Psilocybe cubensis mushroom. Additional
contributors include Liam T. Kane, Seth Crawford, Chen-Shan Chin, Aaron Trippe, and Stephen McLaughlin.
U
NTIL RECENTLY, THE
only Psilocybe cubensis ge-
nome in existence was in-
complete. The new assem-
bly boasts a completeness score of over
97.6% and is 75 times more contigu-
ous than the prior genomes. The mat-
ing loci have been identified and we
have a nice variation map of the genes
involved in psilocybin production. This
is an important step forward in under-
standing how to breed these organisms
and synthesize the psilocybin and oth-
er tryptamines, which appear to be ef-
ficacious in the treatment for a range
of notoriously difficult to treat condi-
tions such as depression, anxiety, and
post-traumatic stress disorder (PTSD).
In fact, the compound has such prom-
ise that the Food and Drug Adminis-
tration (FDA) is considering approv-
al of various therapies and treatments
based on the drug.
Hundreds of mushroom species make
psilocybin, but it is vital to genetical-
ly identify them. Many other mush-
rooms look like Psilocybe cubensis, but
are lethal to humans. Understand-
ing these different species at the ge-
netic level is necessary to furthering
20 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no. 5 cannabissciencetech.com
BY F R A N K P R I S C A R O
research and keeping patients and cli-
nicians alike safe. And now, because of
this new reference sequence, that is en-
tirely possible.
Medicinal Genomics has already
begun trying to understand the dif-
ferent psilocybin-producing mush-
rooms. The team recently published
a paper (1), now under peer-review,
in which they sequenced 81 addition-
al mushroom spore samples over five
species: Psilocybe tampanensis, Psilocy-
be cubensis, Psilocybe azurescens, Psil-
ocybe galindoi, and Psilocybe mexicana.
The paper has found alternative psilo-
cybin synthase pathways and demon-
strates the value of high-quality. The
company has also launched Psilocyd-
ia (2), the largest digital repository of
psychoactive mushroom genomes.
In the process of sequencing 81 dif-
ferent spore samples, psilocybe mi-
crobiomes became apparent. These
bacterial passengers may assist in un-
derstanding the common contami-
nants that plague mushroom growth.
Bacteria replicate or double every 20
to 30 minutes, but fungi often require
2–3 hours to double. Any bacterial
contamination in a fungal growth can
wreak havoc and overtake the growth.
This requires attention to sterile tech-
nique during fungal growth and active
screening of bacterial contaminants
that might co-inhabit a spore sample.
To address the problem, Medicinal
Genomics is developing a new multi-
plex quantitative polymerase chain re-
action (qPCR) assay that targets 16S
ribosomal RNA as well as two genes
in the Psilocybin synthesis pathway
unique to Psilocybe cubensis (P. cuben-
sis). As a result, the assay will ensure
the elimination of potential bacterial
contaminants that might impact yield
or growth. It will also confirm prop-
er fungal growth because the primers
are known to not amplify other toxic
mushrooms that might be mistaken for
P. cubensis.
References
(1) https://f1000research.com/articles/10-281/v2.
(2) h ttps://www.psilocydia.net/.
About the Author
FRANK PRISCARO is with Medicinal Genomics.
Direct correspondence to: frank.priscaro@
medicinalgenomics.com
 feature

Psilocybin Therapy
for PTSD and Depression
BY JA M E S S C H WA R T Z

The therapeutic role of psychedelics goes back thousands of years and more recently to the 1950s and
1960s, but new research and the application of the principles of microdosing have created renewed
interest in the power of psychedelics. In the age of modern medicine and pharmaco-therapies for all
types of psychiatric disorders it has become widely known over the last 50 years that selective serotonin
reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) do not help everyone.
In addition, some disorders are treatment-resistant to current US Food and Drug Administration (FDA)
approved therapies. In 2019, the FDA approved the drug Spravato (ketamine) for use in treating depression;
this approval was a catalyst to revisiting psychedelics as a therapy for a variety of psychiatric disorders.
Image credit: Iarygin Andrii/ adobe.stock.com

T
WO OF THE most common diagnoses that show
response to psychedelic therapy are depression
and post-traumatic stress disorder (PTSD). Be-
cause of the similarities in the way that the brain
stores emotional experiences we will consider both diagno-
ses in parallel when it comes to the effects of how psychedelic
therapy works. Trauma is coded in the brain by the amygdala
and then the frontal lobes before various parts of the experi-
ence are encoded across many areas of the brain. But it is the
amygdala that responds to, defines, and regulates emotion,
as well as associated feelings of sadness, joy, or pain with the
memory as it is stored.

cannabissciencetech.com |
    
Psychedelics: New Frontiers in Alternative Medicine 21
feature / research
The amygdala is part of the lim-
bic system, a network of interconnect-
ed structures responsible for emotion
and behavioral responses to stimu-
li and events. The amygdala activates
the “fight or flight” response when we
encounter danger or feel unsafe. Fight
or flight is a survival response to both
physical and emotional danger. Once
the amygdala is triggered, messag-
es are sent to the frontal lobes for eval-
uation. The frontal lobes are respon-
sible for executive function. This area
of the brain can evaluate the stimulus
and determine an appropriate response,
which includes overriding the amyg-
dala’s survival response. If the amyg-
dala does activate the fight or flight
response, the limbic system then acti-
vates multiple physiological systems, in-
cluding the sympathetic nervous sys-
tem, which stimulates the release of a
It is within this system adrenaline (ep-
inephrine) and norepinephrine, as well
as other stress hormones (1). It is within
this system and during this process that
memories and associated emotions are
stored in the brain. This is why PTSD
and depression are closely related with
respect to how the messages are coded,
stored, and accessed. With depression,
the brain has trouble accessing joy asso-
ciated with memories, whereas traumat-
ic experiences are encoded with nega-
tive emotions; both require rewiring.
Trauma is an extreme form of emo-
tional response to a distressing experi-
ence often caused by a sudden or unpre-
dictable event (1). As we have seen and
experienced with the COVID-19 pan-
demic, no one is able to avoid traumat-
ic events. Trauma affects us all, and
we each respond differently. Traumat-
ic events include but are not limited to:
the loss of a loved one, a violent situa-
tion, physical abuse, a car accident, or
military combat experience. The trau-
ma is stored in the brain, and when
these memories are triggered, they can
22 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no.   |  cannabissciencetech.com
undermine a person’s sense of safety
and trigger hypervigilance (1).
Once trauma is stored in the brain,
it manifests in numerous ways. It can
be subtle or obvious and often destruc-
tive. How someone responds to trau-
ma is determined by multiple factors in-
cluding past experiences, the type of
event, the developmental stage and pro-
cesses of the person experiencing the
event, and the social and cultural envi-
ronment. Manifestations or symptoms
of depression or PTSD can include emo-
tional struggles, sleep disturbances, an-
ger issues, difficulty with profession-
al or personal relationships, and even
physical pain. Living in a high stress de-
fense mode can then lead to “Amygdala
Hijack” which is when the amygdala dis-
ables the frontal lobe and takes control
or “hijacks” the brain.
Previous models of how the brain
processes experience theorized that
we receive stimuli from our environ-
ment, process the stimuli in higher
functioning areas of the brain, and send
out the signals with an appropriate re-
sponse (12). However, new research sug-
gests that the brain predicts what each
unique situation or environmental mod-
el will be based on prior similar sensory
inputs instead of each individual experi-
ence, a “predictive coding” theory. This
is a way for the brain to function more
efficiently when processing new infor-
mation. When errors occur the brain
corrects for the prediction error and ad-
justs the model. Andrew Clark, a cogni-
tive scientist at the University of Edin-
burgh in Edinburgh, Scotland said: “You
experience, in some sense, the world
that you expect to experience,” (12).
Therapeutic analysis of a drug is ob-
served based on an absorption, dis-
tribution, metabolism, and excretion
(ADME) profile to understand and pre-
dict how the drug will work. With re-
spect to FDA-approved drugs like ket-
amine, this data is widely accessible.
However, for drugs such as cannabis or
psilocybin, which are currently Sched-
ule I drugs, research is limited, mak-
ing it difficult to fully understand how
the drugs work. Psilocybin is most com-
monly ingested orally as a raw mush-
room, a capsule of powder, or as a pow-
der mixed with food or tea. Psilocybin is
absorbed in the gut and metabolized by
the liver in first pass metabolism, and
then its most prevalent area of known
action into the body is through the 5HT
2A serotonin receptors (13).
Once ingested, understanding of how
the drug works therapeutically is limit-
ed. Research and clinical trials are need-
ed to discover how psilocybin works in
the brain. Neural imaging indicates that
psilocybin and psychedelics appear to ac-
tivate all areas of the brain, a crucial fac-
tor in understanding why and how psilo-
cybin works. Evidence also suggests that
psilocybin has an exemplary safety pro-
file with few harmful side effects, particu-
larly when microdosing. When adverse
side effects do occur, they appear to be re-
lated to 5HT 2A receptor problems, or re-
ports of the classic “bad trip,” which can
be frightening in the moment, but dis-
appear when the drug wears off. Howev-
er, people with a history of mental illness,
such as schizophrenia or bipolar disorder
should be thoroughly screened, and work
closely with medical professionals if they
are considering psychedelic therapy.
Current knowledge of how psilocy-
bin works is predicated on an under-
standing of the “predictive coding”
model of how the brain processes ex-
periences and the role of the amygdala
and the amygdala “hijack” process. Four
key concepts that lead to the successful
treatment of depression and PTSD with
psilocybin therapy are: neuroplastici-
ty of the brain, the “Default Mode Net-
work,” rewiring of synapses and path-
ways, and surrendering control.
Neuroplasticity means the brain is
malleable and can be reformed, adapted,

regrown, or activated. This function is
key when the goal is to rescript pain-
ful memories. The “Default Mode Net-
work” is the system of the brain that
functions when the brain is in a wakeful
rest, such as daydreaming or ruminat-
ing, a common behavior with depres-
sion. Amygdala hijack occurs when our
brain is stuck in a circuit misfire, where
the same impulse continues to recircu-
late. Psilocybin performs a type of de-
fault mode network reboot, similar to
rebooting a computer.
While the default mode network is
rebooting, psilocybin is rewiring the
neural pathways of stored memory to
establish new pathways disassociating
the experience from the negative emo-
tion connected to the trauma that is
causing depression or PTSD. For psy-
chedelic therapy to truly work, the pa-
tient must be willing to surrender con-
trol by “giving into the drug” and
allowing it to perform its reboot and
rewire, something that is not easy. Our
desire for control is often the source of
our anxieties, believing that if we have
control, we will be safe.
Current Research
What does current clinical research
reveal? Here we’ll review several recent
studies:
1. Trial of Psilocybin versus Escitalo-
pram for Depression (5).
2. Effects of Psilocybin-Assisted
Therapy on Major Depressive Dis-
order: A Randomized Clinical Tri-
al (6)
3. Efficacy of Psychoactive Drugs for
the Treatment of Posttraumatic
Stress Disorder: A Systematic Re-
view of MDMA, Ketamine, LSD, and
Psilocybin (7)
4. Novel Psychopharmacological
Therapies for Psychiatric Disor-
ders: Psilocybin and MDMA (8)
5. Post-Traumatic Stress Disorder Treat-
ment with Psychedelic Drugs (10)
cannabissciencetech.com june 2022  |
research /  feature
Psilocybin Versus Escitalopram
for Depression
The key takeaways from this study
were (5):
• I n a phase 2, double-blind,
randomized, controlled trial
involving patients with long-
standing, moderate-to-severe major
depressive disorder, we compared
psilocybin with Escitalopram.
•P  atients were assigned in a 1:1 ratio
to receive two separate doses of 25
mg of psilocybin 3 weeks apart plus
6 weeks of daily placebo
•O n the basis of the change in
depression scores on the QIDS-
SR-16 at week 6, this trial did not
show a significant difference in
antidepressant effects between
psilocybin and Escitalopram in
a selected group of patients.
Secondary outcomes generally
favored psilocybin over Escitalopram
•N  ote that dosage of psilocybin
used was sub-therapeutic
approximately 25% of a known
microdose dosage of 1–2 mg (raw
mushroom)/kg
Effects of Psilocybin-Assisted
Therapy on Major Depressive
Disorder (MDD)
The key takeaways from this study
were (6):
• T his randomized, waiting list-
controlled clinical trial was
conducted at the Center for
Psychedelic and Consciousness
Research at Johns Hopkins
Bayview Medical Center in
Baltimore, Maryland.
• T wo psilocybin sessions (session 1:
20 mg/70 kg; session 2: 30 mg/70
kg) were given
• I n the overall sample, 17
participants (71%) at week 1 and
17 (71%) at week 4 had a clinically
significant response to the
intervention
• F indings suggest that psilocybin
with therapy is efficacious in
treating MDD, thus extending the
Psychedelics: New Frontiers in Alternative Medicine
results of previous studies of
this intervention in patients with
cancer and depression and of a
nonrandomized study in patients
with treatment-resistant depression
Efficacy of Psychoactive Drugs
for the Treatment of Post-
traumatic Stress Disorder: A
Systematic Review of MDMA,
Ketamine, LSD, and Psilocybin
The key takeaways from this study
were (7):
•S  ystematic review was implemented
to examine the efficacy of MDMA,
ketamine, LSD, and psilocybin for
the treatment of post-traumatic
stress disorder (PTSD)
•O  bservational studies and RCTs
which tested the efficacy of MDMA,
ketamine, LSD, or psilocybin for
reducing PTSD symptoms in adults
• T here was a significant reduction
in self-reported PTSD symptoms
•A  t 12-month follow-up (n = 11),
five participants no longer met
diagnostic criteria for PTSD
Novel Psychopharmacological
Therapies for Psychiatric
Disorders: Psilocybin and MDMA
The key takeaways from this study
were (8):
• 1 2 patients functioning as their
own controls were given two
separate experimental treatment
sessions 1 month apart, receiving
the active drug, psilocybin, on
one occasion and placebo on the
other, in a random order.
•S  ignificant reductions in anxiety
at 1 month and 3 months after
treatment were measured
with the State-Trait Anxiety
Inventory trait anxiety subscale,
and an improvement of mood
was measured with the Beck
Depression Inventory, which
reached significance at 6 months.
•R  esults included safe physiological
and psychological responses
23
feature / research
during treatment sessions. No
clinically significant adverse
events were noted.
• T he association between
psychedelic-induced mystical
experience and therapeutic
outcome when psychedelic
drugs are given under optimal
conditions provides a potentially
valuable therapeutic intervention
for disorders that are otherwise
difficult to treat.
Post-Traumatic Stress Disorder
Treatment with Psychedelic Drugs
The key takeaways from this study
were (10):
• 2 013 study from the University
of South Florida (Hillsborough
County, Florida), supported the
hypothesis that psilocybin can
help break the traumatic cycle
that occurs in patients with PTSD
•S  tephen Ross, MD, a psychiatrist
at NYU Langone (New York, New
York), conducted a study on
terminally-ill cancer patients, and
found that one-time treatment
with psilocybin very quickly
brought relief from distress that
had lasted more than 6 months in
80% of study subjects
•P  atients noted that after being
treated with psilocybin, they felt
their quality of life improve.
• T hey noted that they wanted
to engage more with external
activities, had more energy,
experienced improved
relationships with their family
members, and performed better at
work (4).
Finally, we need to address micro-
dosing which has come to light as one
of the ways to engage in psychedel-
ic therapy without the full effect of a
hallucinogenic “trip.” Microdosing is
24 Psychedelics: New Frontiers in Alternative Medicine  |   vol. 5 no. 5 cannabissciencetech.com
the utilization or consumption of low
sub-sensorium, sub-hallucinogenic dos-
es of a psychedelic drug (3). In current
testing and trials, this is a safer, more
easily tolerated, and therapeutic meth-
od of using psychedelics when a deep
journey is not necessary. Research is
currently underway, exploring micro-
dosing as a means to increase the safety
profile of psychedelic therapy.
Conclusion
In summary, the therapeutic role of
psychedelics goes back thousands of
years, but new research and the appli-
cation of micro-dosing principles have
created renewed interest in the power
of psychedelics. Early research shows
success, but more studies need to be
done. The power to heal the mind with
psychedelics is real.
References
(1) https://www.psychologytoday.
com/us/basics/trauma.
(2) National Center for Biotechnology
Information, U.S. National Library
of Medicine, 8600 Rockville Pike,
Bethesda MD, 20894 https://www.ncbi.
nlm.nih.gov/books/NBK207191/.
(3) T. Anderson, R. Petranker, and A. Christopher,
et al. Harm Reduct. J. 16, 43 (2019). https://
doi.org/10.1186/s12954-019-0308-4.
(4) J.M. Rootman, P. Kryskow, and K. Harvey,
et al. Sci. Rep. 11, 22479 (2021). https://
doi.org/10.1038/s41598-021-01811-4.
(5) R . Carhart-Harris, B. Giribaldi, R. Watts,
M. Baker-Jones, A. Murphy-Beiner, R.
Murphy, J. Martell, A. Blemings, D.
Erritzoe, and D.J. Nutt, N. Engl. J. Med.
384(15), 1402–1411 (2021). doi: 10.1056/
NEJMoa2032994. PMID: 33852780.
(6) A .K. Davis, F.S. Barrett, D.G. May, M.P.
Cosimano, N.D. Sepeda, M.W. Johnson,
P.H. Finan, and R.R. Griffiths, JAMA
Psychiatry 78(5), 481-489 (2021). doi:
10.1001/jamapsychiatry.2020.3285. Erratum
in: JAMA Psychiatry. 2021 Feb 10;: PMID:
33146667; PMCID: PMC7643046.
(7) T. Varker, L. Watson, K. Gibson, D.
Forbes, and M.L. O’Donnell, Journal of
Psychoactive Drugs 53(1), 85-95 (2021),
DOI: 10.1080/02791072.2020.1817639.
(8) M.C. Mithoefer, C.S. Grob, and T.D.
Brewerton, The Lancet Psychiatry 3(5),
481-488 (2016), ISSN 2215-0366, https://
doi.org/10.1016/S2215-0366(15)00576-3.
(https://www.sciencedirect.com/science/
article/pii/S2215036615005763).
(9) Northwest Therapies Trauma Psilocybin
Study Compassionate Use Study
(NWTTPS), https://clinicaltrials.gov/
ct2/show/NCT05042466#wrapper.
(10) 2022 NYU Grossman School of Medicine
Post-Traumatic Stress Disorder Treatment
with Psychedelic Drugs, https://med.nyu.
edu/departments-institutes/population-
health/divisions-sections-centers/
medical-ethics/education/high-school-
bioethics-project/learning-scenarios/
ptsd-treatment-psychedelics.
(11) "How ecstasy and psilocybin are shaking up
psychiatry" Nature 589, 506-509 (2021)doi:
https://doi.org/10.1038/d41586-021-00187-9.
(12) MIND Foundation gGmbH, Boxhagener
Straße 82ª 10245 Berlin, https://mind-
foundation.org/predictive-coding/.
(13) M.K. Madsen, P.M. Fisher, and D.
Burmester, et al., Neuropsychopharmacol.
44, 1328–1334 (2019). https://doi.
org/10.1038/s41386-019-0324-9.
About the Author
JAMES SCHWARTZ, BSN, LNC is a graduate
student in Medical Cannabis Science and
Therapeutics at the University of Maryland
School of Pharmacy in Baltimore, Maryland
and the CEO of Cascade High Organics. Direct
correspondence to: james@cascadehigh.com

The Legal Cannabis
Coalition:
A Closer Look at How Dutch Horticultural
Companies and Scientific Partners Joined Forces
M E G A N L’ H E U R E U X
Dr. Arno Hazekamp, cofounder and board member of Legal Cannabis Coalition as well as
the director and founder of Hazekamp Herbal Consulting, discusses the formation, goals,
research, and education initiatives going on in the newly formed group.
T
HE SUPPLY CHAIN of a cannabinoid
product resembles that of a pharmaceuti-
cal product. Quality must be maintained
throughout source of ingredients, testing
in laboratories, production processing, and carefully
packaged and transported products.
If quality is compromised at any step, the result
will be an inferior product that jeopardizes your
business, consumer trust, and, most importantly,
the health of the patient. One of the most critical
risk points is for laboratories storing reagents and
samples in refrigerators. Like any machine, perfor-
mance of a refrigerator can vary and expire. Thus
resulting in a temperature deviation that could
influence the results of the analytical testing.
regulations: us
As of March 2020, 33 US states have laws allowing
medical use of cannabis, plus another 14 allow the use
of low tetrahydrocannabinol (THC) limited pro-
grams. In addition, 11 states also allow recreational
use or “adult use” (see Figure 1). For a comprehen-
sive state by state overview on legalized medical and
“adult use” cannabis use, visit the National Confer-
Image credit: Microgen/ adobe.stock.com
ence of State Legislatures web page on marijuana
laws (1).
One key good practice (GxP) standard guidance in
the US is from the United States Pharmacopeia Gen-
eral Chapter <1029> “Good Documentation Practices”
(2), that states:
•R
 ecords should be clear, concise, accurate,
cannabissciencetech.com june 2022  |
feature
and legible
•D
 ata entries should be recorded promptly when
actions are performed
•N
 o backdating or postdating
•D
 ocumentation system is needed to ensure data
integrity and availability of current and archived
records
regulations: canada
Documentation is key. As per section 231 of the Can-
nabis Regulations (3–5), license holders (other than
cannabis drug license holders) must maintain records
demonstrating their adherence to the good produc-
tion practices (GPP). License holders must be able to
demonstrate, using records available at the licensed
site, that the activities conducted are compliant.
Have you faced a regulatory audit yet? In Canada,
they started in 2017 following three recalls of canna-
bis for medical use related to the unauthorized use of
pest control products (PCPs). Health Canada began
a series of unannounced inspections and targeted
testing of cannabis products from licensed producers
under the Access to Cannabis for Medical Purposes
Regulations to ensure that only authorized PCPs
were used during the production of cannabis. Later
that year, Health Canada announced it would require
mandatory testing for the presence of pesticide active
ingredients in all cannabis products, before the prod-
ucts could be sold or provided to individuals.
   
Psychedelics: New Frontiers in Alternative Medicine 25
feature / research
Cannabis and
Psychedelics Research:
A Conversation with Dr. Denise Vidot
BY M E G A N L' H E U R E U X
W
e recently connected with Dr. Denise C.
Vidot, an epidemiologist at the Universi-
ty of Miami and Founder of the Interna-
tional Cannabis & Psychedelic Research
Collaborative. Here, Dr. Vidot shares her research back-
ground, a little overview of her talk from this year's Can-
nabis Science Conferences West titled, “Co-Use of Can-
nabis and Psilocybin to Manage Mental Health Amid the
COVID-19 Pandemic: Preliminary Results from the Inter-
national COVID-19 Cannabis Health Study,” and more. Dr.
Vidot’s research focuses on the biological, psychosocial,
and societal implications of cannabis and psychedelic use
on human health across the lifespan.
Can you tell us a little bit about yourself
Q: and how you became interested in the
cannabis industry?
Dr. Denise Vidot: Yes. Well, first of all, I am a
A: cannabis epidemiologist at the University of Miami.
I am a very passionate researcher that focuses on the brain,
heart, and gut axis. I’m sure I’ll be talking about that later,
but it’s important for me to start with that, because literally
every piece of research that I conduct, whether it’s
regarding cannabis or psychedelics, is really to characterize
how important that brain, heart, and gut axis is.
Can you tell us about your research related
Q: to cannabis, and have any of your findings
surprised you?
Dr. Vidot: Where do I even start? In my research,
A: as an epidemiologist, I have the luxury of being able
to study multiple diseases and illnesses at the same time.
One of my most exciting findings that I’ve been collecting
over multiple studies—so it’s not just one study that is
26 Psychedelics: New Frontiers in Alternative Medicine   
|  vol. 5 no. 5 cannabissciencetech.com
showing this—but I’m sure everyone has heard the
hypothesis or the stigma that cannabis gives you the
munchies and you’re just sitting on the couch, you know,
that stigma that we are used to seeing in popular media.
Well, I have to bust the popular media’s bubble because the
data suggests otherwise. In fact, some of my studies are
showing that cannabis consumers have a lower prevalence
of metabolic syndrome, and that is the risk factors that lead
to cardiovascular disease and so on. So, I would say I have
lots of findings, but that’s one that immediately jumped to
my head because it directly goes against what the stigma of
cannabis is.
How did your work in the cannabis industry
Q: lead you to your research and work with
psilocybin?
Dr. Vidot: That’s a really interesting story. I’ve
A: been studying cannabis for over 11 years now. So, if
we just picture what the industry looked like 11 years ago, I
mean, I don’t even know if we would be having this
conversation 11 years ago. Right? Just to paint the picture, I
was at the University of Miami. I felt like I was in a silo,
really, as the only cannabis researcher. Of course, nobody
really called it cannabis 10 years ago, it was all marijuana or
weed. So, I was known as the “weed doc.” Right? But
throughout that, working with this highly stigmatized
plant, I’ve noticed, even throughout the years, that some of
the participants were mentioning that they were using
other substances, such as fungi or natural remedies, and
one of those was mushrooms. But at the time, I didn’t
really know much about that, and I was so focused on
making sure that I had the cannabis research and making
sure that I could do cannabis research at the university, for
example. I was very focused on that.

Then, of course, the pandemic hit,
and at that time, I was like, “Well, you
know what? I could die tomorrow.”
I’m just being completely honest with
everyone. As epidemiologists, we were
the front-line counters of who had
COVID-19 and all the ways that we can
prevent it. And in my mind, I was think-
ing, “Hello, cannabis.” When we started
to see all these mental health outcomes,
I also started paying attention to what
psychedelics could do. So, it was during
that study, the COVID Cannabis Health
Study, that we started asking questions
about psychedelics for the first time in
a structured way. I’ve been studying it
non-structured through, you know, pa-
tient conversations and qualitative in-
terviews, but this was the first time that
we standardized the way that we col-
lected the data.
What were patients saying
when you when you started
Q: seeing those results? What
kind of reports were
coming in?
Dr. Vidot: Well, it’s funny
A: because some of the patients
that were part of some of my other
studies said “Dr. Vidot, I’m glad you’re
finally asking this question.” And I said,
“Oh, well, you should have told me.” But
some of the accounts that we were
getting was that psychedelics were
helping them cope with the uncertainty
of the pandemic and giving them
opportunities to be more within
themselves. Some of the data (which I
presented at Cannabis Science Confer-
ence West hot off the press) actual
hardcore data that’s being analyzed as
we speak by our analysts of what
psilocybin in conjunction with cannabis
actually did when it came to generalized
anxiety disorder and also depression. I
can tell you now that preliminary results
are showing that those who consumed
both cannabis and psilocybin had lower
cannabissciencetech.com june 2022  |
research /  feature
prevalence of major depressive disorder
based on their self-reported measures.
Did those patients report on
Q: how much they were taking
of both or either one?
Dr. Vidot: Unfortunately, for
A: the psychedelics, we did not get
the dose or even the frequency. We just
know, yes or no, within the past 30 days
or past year. With the cannabis, we do
know the number of days and the
amount or dose. We also have informa-
tion about the cannabinoids that were
consumed. So, in the next study, we’re
going to be a lot more strategic about
how we ask those questions.
As you mentioned before, at
this year’s Cannabis Science
Conference West your talk
was titled “Co-Use of
Cannabis and Psilocybin to
Q: Manage Mental Health Amid
the COVID-19 Pandemic:
Preliminary Results from the
International COVID-19
Cannabis Health Study.” Can
you share a little bit more of
Psychedelics: New Frontiers in Alternative Medicine
what inspired you to present
on this topic and what were
Q: you most excited to share
with attendees?
A:
Dr. Vidot: Yes. Well, what
inspired me to talk about this
was when I was at the Cannabis Science
Conference East in the fall of 2021,
when I gave a presentation there. It was
actually my first time being live at a
conference after COVID-19. That
energy of all the scientists, all of us
together, and really we built a family at
thatconference—that inspired me.
Now, I don’t even see myself not going
to that conference anymore because I
just get so excited. I think it was there
that I saw that Josh Crossney, who’s
the founder and now Director of
Cannabis Events at MJH Life Sciences,
had the sign saying “Coming soon,
psychedelics and cannabis.” I was like,
“Oh wow.” So, now my research has a
space to be shared because before I
didn’t. You hear a lot about cannabis
research, you hear a lot about psyche-
delics, especially now. Everyone wants
to talk about psychedelics suddenly,
right? Who’s talking about the co-use,
27
feature / research
you know, and who’s talking about it in
a way that’s not stigmatized? Because
the times that I do hear about cannabis
and psilocybin being used together, it’s
usually, “Oh, don’t do that,” or, “There
is no data about that.” Well, somebody
has to start collecting that data. And
that’s what I’m so excited about, and
that’s why I chose that topic, because
we have multiple studies in our lab.
We’re also studying some synthet-
ic versions which are not my favorite.
I, of course, appreciate nature best.
But I chose this topic because the pas-
sion that I felt from the audience dur-
ing the Cannabis Science Conference
in the past shows me that this is the
audience that I’d like to show this data
to for the very first time, because this
data is going to be published. But to be
able to share it live in front of this au-
dience, I think is the best. And I chose
this topic in particular because we
have multiple measures in that study,
but I chose this topic because, as a
globe, all of us have PTSD, let’s be real.
And that PTSD needs to be managed
because over time, as we know, it will
compound. And, if I have it my way as
an epidemiologist, I will not let people
who hear my voice let that compound
because there are ways to take action,
and those ways include nature.
Are you studying any
Q: other psychedelics
or just psilocybin?
Dr. Vidot: Yeah, we’re studying
A: ayahuasca. That’s self-reported.
It’s nowhere near as extensive as our
psilocybin work, of course. We are also
studying ketamine. I collaborate very
closely with Dr. Michelle Weiner in
Miami and South Florida, and we have
two ketamine studies. In fact, we are
getting ready to start disseminating the
results here shortly, where we’re
comparing intramuscular and oral
administration and lots of fun things.
28 Psychedelics: New Frontiers in Alternative Medicine
So, you’ve seen people
responding in that they’re
using psilocybin, and part of
that came about because of
your COVID-19 research.
Because of the COVID-19
Q: pandemic, your research kind
of fast tracked in this area. Do
you think it would have
eventually reached this point
even without the pandemic,
or is it too hard to say?
Dr. Vidot: That is a fantastic
A: question. I think that the speed
at which the mental health outcomes that
my laboratory is analyzing and dissemi-
nating may have been accelerated based
on the fact that there’s a pandemic. But I
believe that our lab would have been
focusing on this either way, but most like-
ly, we would have been focusing more on
the physical health outcomes of
psilocybin, because we haven’t even
talked about that yet too, but I have a
whole other branch that’s focused on
what is psilocybin doing to the heart rate,
how is it dealing with inflammation,
getting actual inflammation markers
from the blood? So, to directly answer
your question, I do believe that the
pandemic accelerated our mental health
branch of the laboratory in regard to our
psilocybin research. And it’s a little sad
for me to say that as a reality, but that’s
where we are today.
What important information
do you hope attendees
Q: learned from your pres-
entation that they wouldn’t
know otherwise?
Dr. Vidot: Oh, number one,
A: that not all cannabis is created
equal, and already my hypotheses are
showing that not all fungi are equal. I
think that if attendees don’t remember
anything else from what I say, I just
want them to leave knowing that it is
important to understand what type of
|  vol. 5 no. 5 cannabissciencetech.com
cannabis is being consumed, and also,
it’s important to understand that
psilocybin—and psychedelics in
general—it’s not just about taking the
fungi or taking the substance. Integra-
tion is so important, and I’m talking
about pre-integration, during integra-
tion, and post integration. So, we talked
a little bit about that during the
presentation as well.
Do you face any unique
Q: challenges with researching
cannabis and psychedelics?
Dr. Vidot: Yes, that is the
A: definition of what we are
facing. I think that if anyone wants to
study cannabis and psychedelics, first
of all, you must have passion. You have
to have a good why. And I know that
sounds pretty cliché because every-
one’s always like, “What’s your why?”
But really, if you are not passionate for
the right reason, when it comes to
cannabis research and psychedelic
research, you can easily get caught up.
And when I say caught up, what does
that mean? Getting caught up in the
wrong, or trying to do the wrong types
of studies for what reason. I also think
that the regulatory guidelines make it
challenging, especially for the type of
research that I want to do.
I always talk about how my collabo-
rators and I have multiple protocols and
grants already written so that when the
National Institutes of Health (NIH) al-
lows us (and, yes, I mean allows us), to
conduct randomized controlled trials
with cannabis in particular, we’re ready
to go. So, I would say that’s the big-
gest challenge. And then also the stig-
ma. You know there is the plant stigma
and then the reality of the world that
we live in today, I am a young Latina,
well, I present as a young Latina wom-
an, but I am a cannabis and psychedelic
epidemiologist researcher with a large
lab. And I think that stigma sometimes

also makes it challenging to conduct re-
search and be taken seriously.
Do you want to share any
Q: experiences of how you got
to where you are?
Dr. Vidot: Sure, I can definitely
A: talk about that. I’m the eldest of
seven children. A true Puerto Rican here.
I’m so close to my father. And my father
was diagnosed with multiple myeloma
cancer, common variable immunodefi-
ciency disorder, and also scleroderma.
Those are three incurable diseases that
are chronic, and the mortality rate is not
to be discussed with smiles. Right? So,
seeing my father go through all of that,
the opioid fog, the chemo, all these
pharmaceuticals getting thrown at him,
every time he had a negative side effect,
“Oh, don’t worry. There’s a pill for that.”
It wasn’t until he started consuming
cannabis. Cannabis is what helped him.
When I was in high school, I saw that.
I also saw the stigma related to that. So,
in short, watching my father go through
that as well as watching some other so-
cial injustices happen in my neighbor-
hood regarding cannabis really inspired
me to say, “What can I do?” I have al-
ways been very passionate about sci-
ence, even at a young age. So rath-
er than be a physician, who basically
just practices what the researchers tell
you, I decided I wanted to do research
and prove to the world that there is evi-
dence that suggests that cannabis is not
a gateway drug. Cannabis is not going
to do all these things that Reefer Mad-
ness and all these other stigmas that
propaganda has shown us.
Do you have any advice
for other researchers who
Q: might want to conduct
similar studies?
Dr. Vidot: Don’t quit. Immedi-
A: ately, that’s my first thing.
Don’t quit. I’ve found that the more
cannabissciencetech.com june 2022  |
research /  feature
pressure and more resistance that I
get, that means I’m onto something.
So, I would encourage any other
researcher, especially in the cannabis
space—I’m still new to psychedelics,
so it’s a little irresponsible for me to
communicate about that—but
especially for the cannabis space, stay
strong. If you are at a university or an
area that cannabis research is not
taking place, look for those who are. At
the University of Miami, as I men-
tioned, 11 years ago no one else was
doing cannabis research. So, what did I
do? I was following the Dr. Meg
Haney's of the world at Columbia
University. I was just looking at their
research, trying to email them, and
asking if I could volunteer in their labs.
I have a very open-door policy in my
laboratory, for example. So, if you’re
interested in getting your hands wet in
some cannabis or psychedelic research,
feel free to email me. But it just takes
emailing someone because, especially
I’ve noticed in the cannabis and psych-
edelics space, we’re open, especially if
you show passion or that you’re excit-
ed for the right reason and not just try-
ing to make millions. Let’s be honest,
you already know there’s a sector that’s
in it for the money. But overall, stay
strong and don’t quit. It’s worth it.
Do you want to share a little
bit about your talk from the
Q: Fall 2021 Cannabis Science
Conference on the brain,
heart, and gut axis?
Dr. Vidot: Yes, as a matter of
A: fact, that study is still going on.
But the results are very similar, though
so that’s good news. But at the 2021
conference, I spoke about cannabis and
the impact on the brain, heart, and gut
axis. I showed how different types of
cannabinoids can have different
outcomes on multiple organs. I also
summarized how every single one of us
Psychedelics: New Frontiers in Alternative Medicine
has an endocannabinoid system. And
that system is why cannabis can
influence our mental and physical
health. Just as a little teaser here, I
want to mention that one of my next
endeavors or what I’m working on right
now is trying to understand how
psilocybin in particular engages with
the endocannabinoid system. Some
people are like, “Oh, no, Denise, you
know, Dr. V, you’re crazy. That’s
cannabis.” Okay—you heard it here
first. That’s what I’m looking at.
What is next for your
research with cannabis and
Q: psychedelics? Do you want
to share any other future
work you’re planning?
Dr. Vidot: Right now, we’re also
A: planning next stages for things.
A lot of our work, especially in the
psychedelic space includes a lot of pilot
studies, so we’re trying to get that
evidence to prove that we should do a
larger study. So, right now, we’re getting
ready to relaunch our psychedelic study
on COVID, but this time, asking those
questions about the dosing, asking
questions about what their pre- and
post-integration practices were, if any.
We’re definitely looking deeper
into the long-term impact of psyche-
delics and during COVID, because as
we know, the situation, when you have
COVID is one thing, but what happens
four months after COVID, when you’re
still having some mental fog? What
happens a year after COVID? What
happens five years after COVID? We
don’t know yet, but our laboratory is
setting up an infrastructure up so that
we can study that and be able to answer
those questions, so that if another pan-
demic comes at least we’ll know. We’ll
have that data of what happened last
time, because as of this point, we don’t
have data on psychedelics and past pan-
demics, past illnesses of this caliber.
29
feature / research
So, in short, my laboratory is so fo-
cused on creating this foundation for
longevity and sustainability. It’s my
goal to make this a transgenerational
type of study so that even after I leave
this time construct, that it’s continuing
and growing.
Q: Is the study nationwide?
Dr. Vidot: The study is global,
A: actually. Yes, it was an inter-
net-based study, and I have collabora-
tors in multiple countries and we,
basically, collaborated together and
dispersed it. So, as of the last time that
I looked at the numbers, we have over
3000 participants, and I would say
about 1000 of them are not in the
United States. The majority of the
global respondents are from New
Zealand, Canada, United Kingdom, and
there’s one other country that was
overwhelming that I can’t recall off the
top of my mind now.
Where can patients go if
Q: they’re interested in joining
the next phase?
Dr. Vidot: They can look up a
A: bit.ly link, it’s very easy to
remember. It is bit.ly/cannabiscovid and
that’ll bring you straight to our survey,
and you can fill it out then for sure.
So back to the conference,
what were you most excited
Q: to learn at the Cannabis
Science Conference West?
30 Psychedelics: New Frontiers in Alternative Medicine
Dr. Vidot: I was excited to
A: learn how my friends, col-
leagues, and collaborators are being
innovative in this field of psychedelics
and cannabis. You know, especially
with COVID. We keep talking about
this, but, you know, with COVID, I feel
that science blossomed so fast. It
exploded, right? I’m just so excited to
watch them live, present their research
and knowing what our colleagues were
going through during the pandemic,
trying to still conduct research, trying
to help our patients, helping our study
participants. So, it’s kind of like a show
and tell of the family. Let’s see what we
got, you know, so I’m really excited and
I know I keep saying that, but really,
I’m just excited to get back and
network and see the cannabis and
psychedelic family.
What do you hope to see
happen in the next five
Q: years regarding cannabis
and psychedelic research?
Dr. Vidot: Well, regarding the
A: next five years with research, I
would like to see lots more studies
going on in our lab. No, just kidding.
But for real, I would like to see rigorous
studies. I would like to see more
randomized controlled trials. This
would require, of course, the removal
of the federal block against cannabis
and scientists. But for sure, I would
love to see randomized controlled
trials. And with psychedelics, I would
like to see scientists be authentic. I
|  vol. 5 no. 5 cannabissciencetech.com
would like to see scientists that are not
just making assumptions and making
sure that they’re making strategic,
intentional research, because this is not
a game. I know we should approach any
type of research as not a game. You
know, life is not a game. Right now, we
are at a point in time where it’s so
pivotal on how we treat psychedelics,
especially with how we know it
happened with cannabis. Let’s not do
the same thing with psychedelics,
please.
Is there anything else you’d
Q: like to add?
Dr. Vidot: I guess the last thing
A: I’d like to add is for anyone
who attended the conference or plans
to attend future events that I'm
speaking at, please make sure you stop
by and say hello. Just say hello to me
because there’s nothing better than
making these connections because you
never know who you say hello to. If 10
years from now, and number one, if
you’re going to see them again or in the
future, you’re going to collaborate.
There are some people who I met five
years ago and now we talk all the time
doing research and I never imagined
that we would, so be sure to say hello.
For more information on Dr. Vidot's
research, please visit http://herbalheart-
study.com/denise-c-vidot-phd/.
Cannabis Patient Care™ is the new
resource for cannabis patients, doctors,
budtenders, dispensaries, and advocates
to education themselves on the benefits
and treatment options cannabis provides.
Our mission is to help our readers on the
path to wellness by presenting cannabis
as a viable treatment option.

a supplement to Cannabis Science and Technology ®

november 2020 vol 1 no 1

●

Visit our website to start

Post-Traumatic your free subscription
Stress to Post-
Traumatic CannaPatientCare.com
Growth
How Medical
Cannabis Is
Helping Veterans
with PTSD

Sponsored by Created in partnership with

www.cannabissciencetech.com
 September 14-16, 2022
Baltimore Convention Center
Baltimore, MD
life sciences
™

Join us at the world’s largest scientific &

medical cannabis event!

Early Bird Discount • 25% off through June 30

* Canna Boot Camp * Analytical/Scientific * Networking Mixers

* Exciting Keynotes Experts * Global KOLs
* Huge Exhibit Floor * Medical/Wellness * and much more!
* Cultivation Gurus Professionals

Educational Tracks
Analytical Science | Medical Science | Cultivation Science | Hemp Science | NEW! Psychedelic Science

Make your plans today to attend and/or exhibit!

Learn More at CannabisScienceConference.com