MDMA-Assistive

Psychotherapy as
Treatment
for PTSDD

By:
Noah Carlin
The Feasibility of MDMA-Assistive Psychotherapy as Treatment for
Posttraumatic Stress Disorder in Veterans

Noah Carlin
Department of English
Florida State University
ISC 4404, Section 002
April 09, 2019
Word Count: 3,302

Cover Photograph: U.S. Air Force photo by Master Sgt. Kevin Milliken
Table of Contents

List of Tables and Figures.............................................................................................................. iii

Executive Summary ....................................................................................................................... iv
1 Introduction ............................................................................................................................. 1
2 Current Available Treatment Models ..................................................................................... 2
2.1 Prolonged Exposure Therapy............................................................................................... 2
2.2 Cognitive Behaviorial Therapy ........................................................................................... 3
2.3 Pharmeceutical Intervention ................................................................................................ 4
3 MDMA-Assistive Psychotherapy ........................................................................................... 6
3.1 MAPS Phase I and II Clincal Trials .................................................................................... 8
3.2 Current Phase III Clinical Trials ........................................................................................ 10
4 Challenges to MDMA-Assistive Psychotherapy ................................................................. 10
5 Conclusion ............................................................................................................................ 11
References ..................................................................................................................................... 12

ii
List of Figures

Figures
Figure 1: Prolonged Exposure Therapy Image ................................................................................2
Figure 2: CPT Treatment Structures ................................................................................................4
Figure 3: RU Pharmacotherapy Recommendations .........................................................................5
Figure 4: RU Pharmacotherapy Recommendations .........................................................................6
Figure 5: MAPS Phase II Clinical Trial Dose .................................................................................7
Figure 6: MAPS MDMA-Assistive Psychotherapy Treatment Structure .......................................8
Figure 7: MAPS MDMA-Assistive Psychotherapy Phase II Clinical Trial Results .......................9
Figure 8: Long-Term Results ...........................................................................................................9

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Executive Summary

MDMA-Assistive Psychotherapy is an emerging treatment option for posttraumatic stress

disorder (PTSD) with promising long-term success-rates shown in recent randomized clinical
trials conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is
currently conducting Phase III trials that, if as statistically-successful as previous trials, will
result in FDA approval to allow for MDMA-assisted psychotherapy prescriptions by the early
2020s.

According to the Department of Defense/ Veterans Affairs, veteran suicide rates have been
steadily rising since 2005—with more than 6,000 suicides committed per year since 2008. These
are just the reported cases; there are thousands more veterans living with PTSD and struggling
everyday to manage symptoms of the disorder. Until recently, psychotherapy and
pharmacotherapy have been the only available treatment options for PTSD.

While psychotherapy and pharmacotherapy in combination with psychotherapy has been

successful at treating PTSD in the past, there is still a steadily rising rate of Veteran suicides and
even more people with PTSD going untreated or receiving subpar alleviation of symptoms.

This report looks at two different psychotherapy methods, as well as pharmacotherapy

conjunction, in terms of their defined methodology and execution:

 Prolonged Exposure Therapy (PE)

 Cognitive Processing Therapy (CPT)

 Pharmacotherapy

Then it takes a look at MDMA-Assistive Psychotherapy in terms of recently defined

methodology, execution, and trial results. According to MAPS Phase II clinical trial results,
those who received MDMA-Assistive Psychotherapy treatment saw a 61% decrease in PTSD
symptoms two months after treatment; compare that with 23% decrease in those receiving
placebo and psychotherapy. One year later, the MDMA group reported a 68% decrease in PTSD
symptoms.

If MAPS Phase III trials go as projected, and MDMA-assistive psychotherapy is approved by the
FDA for prescription, there are still several socioeconomic hurdles to jump through before the
treatment becomes a viable option for a large, diverse population. However, based on strong
statistical evidence emerging from MAPS Phase I and II trials, MDMA-assistive psychotherapy
has enormous therapeutic potential in the treatment of PTSD, and should be considered as
treatment—especially for veterans—in the near-future.

iv
1 Introduction
“I did not want to get close to my new babies for fear I may get deployed again. A big piece of
me wanted to go back to battle because the battlefield made sense; coming home to emails,
memorandums and unit “politics” did not. I also knew that if I went back, a bigger piece of me
did not want to come back home again.” – U.S. Army Chaplain (Maj.) Carlos C. Huerta

For tens of thousands of veterans, the horrors of war pale in comparison to what happens when
they finally return home from the war-zone. Soldiers have been conditioned to the high-strung
anxieties of battle and grown physiologically used to dealing with very traumatic events on a
daily basis. When they return home where danger isn’t lurking around every corner and things
are far slower and safer, they often experience intense feelings of disillusionment, paranoia,
frustration, fear, and alienation. These feelings mimic the kinds of hair-trigger reactions soldiers
are expected to have in a fire-fight, but that serve no practical purpose once back at home.

I am referring to the symptoms associated with Post Traumatic Stress Disorder (PTSD). If not
properly addressed, these issues can spiral into intense psychosocial issues manifesting in any
number of debilitating and horrific ways.

According to data collected by the Department of Veteran Affairs, there’s been a steady increase
in veteran suicide rates since 2005—with more than 6,000 committed per year since 2008
(Department of Defense/VA). PTSD is the biggest contributing factor to this increase. This is a
problem not just for those afflicted with PTSD, but for the rest of American society as well.
Without proper treatment, PTSD can render veterans unable for reintroduction as productive
members of society, and creates a need for them to be cared for in ways they cannot handle on
their own. The scope of this report is to glimpse a recent method of treatment with far higher
success rates than current models have yielded: looking at MDMA-Assistive Psychotherapy as a
treatment option for people suffering from PTSD.

This report utilizes peer-reviewed studies about recovery rates for PTSD patients treated with
Processing Therapy, Cognitive Behavioral Therapy, pharmacotherapy, and MDMA-assistive
psychotherapy. The goal is not to demonize any particular method of treatment, rather it is to
analyze therapeutic potential to see if there is a confluence of treatment available that would
alleviate the hardships for those currently afflicted with PTSD.

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2 Current Treatment Options
For those currently living with PTSD, there are a few available treatment options that require
long-term commitment for the patient, physicians and therapists involved in treatment process.
Popular options include Prolonged Exposure Therapy (PE), Cognitive Behavioral Therapy
(CBT), pharmaceutical intervention, and often involve a confluence of therapy and
pharmaceuticals before patients see results.

2.1 Prolonged Exposure Therapy

Prolonged Exposure Therapy comes
recommended by both the American
Psychiatric Association and Dept. of
Defense/Veterans Affairs. PE is based
on emotional processing theory (Foa and
Kozak, 1986), which “Contends that
emotions are represented by information
structures in memory, and anxiety occurs
when an information structure that
serves as program to escape or avoid
danger is activated.” The thought is the
fear associated with the trauma is stored
in memory as a “cognitive structure”
(Watkins et. al., 2018) containing
reality-based depictions of the trauma,
including learned fear responses and
meaning-association surrounding the
traumatic event. (Watkins et. al., 2018)
However, according to leading
Figure 1: Soldier with PTSD receiving Prolonged Exposure
researchers on anxiety disorders, Edna Therapy. Source: Bob Woodruff Foundation
Foa Michael Kozack, fear structures The greatest amount of land-based wind energy is available
“may become problematic when the association between
in the Great stimulus
Plains elements
– away from do not
most major loadaccurately
centers.
reflect the real world.” (Watkins et. al., 2018) When
Source: physiological
Adapted from Elliot escape and/or
& Schwartz, avoidance
1993.
responses are triggered by something innocuous, the excessive response interferes with adaptive
behavior and innocuous stimuli and the fear-response elements stored as memory are
“incorrectly associated with threat and danger.” (Watkins et. al., 2018)

PE typically includes 8-12 sessions lasting 1.5 hours, supplemented with two hours of daily self-
practice and phone contact between sessions. (Powch, 2011) Within the context of therapeutic
guidance, the trauma survivor approaches the trauma memory long and often enough to
emotionally process the trauma and experience a reduction in anxiety and fear-responses so that
new learning pathways can be built to better understand the trauma, the fear-response, and
eventually to disassociate the trauma from the fear-response. (Foa and Kozak 1986)

2
PE has been shown to be one of the most effective treatments for PTSD in individuals that are
able to stick with the regimen co-created by the therapist and patient to effectively treat the
disorder: “Recovery rates in psychotherapy randomized clinical trials can reach 70–80% among
individuals who complete treatment…. However, dropout plagues virtually every treatment trial,
leading to average recovery rates in intent-to-treat analyses of only around 40%.” (Hog et. al.,
2014)

Treatment drop-outs occur due to a wide array of factors: from patients feeling like they can
manage on their own, to work interference, related mental illness, lack of therapeutic benefit,
insufficient time, stigma, etc. (Najavits, 2015)

2.2 Cognitive Processing Therapy

Cognitive Processing Therapy also comes recommended by the American Psychiatric
Association and the Dept. of Defense/Veterans Affairs. CPT was originally developed to treat
symptoms of PTSD in rape victims; it is based on an information processing theory of PTSD that
incorporates prolonged exposure, psychoeducation, and cognitive structure. (Resick and
Schnicke, 1992) CPT postulates that following the traumatic event, survivors attempt to make
sense of it and often end up with a distorted understanding regarding themselves, others, and the
world. (Watkins et. al., 2018) In an attempt to integrate the traumatic event with their prior
locus’ of logic and relations, survivors will often assimilate, accommodate, or over-
accommodate. (Watkins et. al., 2018) Assimilation occurs when new information is altered in
order to affirm prior beliefs, which may result in self-blame: An example of assimilation is
“because I didn’t yell loud enough, the attack was my fault.” (Watkins et. al., 2018)
Accommodation occurs when prior beliefs are altered to accommodate new learning: An
example of accommodation is, “I could not have done anything to prevent being assaulted.”
(Watkins et. al., 2018) Over-accommodation involves changing ones’ beliefs to prevent future
trauma from happening, which may result in unrealistic beliefs about the world, or about people
being distrustful and threatening: An example of over-accommodation is, “because X happened,
I can’t trust anybody.” (Watkins et. al., 2018) CPT aims at cognitive activation of the traumatic
memory while identifying harmful beliefs (those assimilated or over-accommodated) stemming
from the traumatic event. The primary end-goal of CPT is to shift prior beliefs towards
accommodation. (Resick and Schnicke, 1992)

3
 CPT typically includes 12
weekly sessions consisting
of cognitive therapy and
exposure therapy that
focuses on learning new
skills to challenge
assimilated and over-
accommodated beliefs
surrounding the trauma
memory. (Watkins et. al.,
2018) Within the context of
therapeutic guidance, the
trauma survivor learns about
the psychoeducational tools
required to appropriately
reframe and approach the
traumatic memory, and how
to utilize those tools to
Figure 2: CPT Treatment Structures. Source: Dept. of Veterans Affairs Medical updated cognitive structure.
Center. The goal is to equip the
patient with the necessary
knowledge to alter their maladaptive beliefs and replace them with adaptive, accommodated
beliefs. (Watkins et. al., 2018) Although CPT was introduced as trauma therapy for rape victims,
it has shown to be equally effective across all types of trauma populations.

Treatment drop-outs are also an issue for CPT, especially due to the long duration of time in the
entire recovery process. Drop-outs occur due to a wide array of factors: from patients feeling like
they can manage on their own, to work interference, related mental illness, lack of therapeutic
benefit, insufficient time, stigma, etc. (Najavits, 2015)

2.3 Pharmacotherapy

Along with regular psychotherapy, there are many people who opt for a pharmaceutical
approach. However, this is more often than not recommended in conjunction with some form of
trauma psychotherapy. Pharmacotherapy alone is generally not recommended; pharmaceutical
medications can potentially alleviate several prominent symptoms of PTSD, they do not address
the psychological root of the trauma. (Watkins et. al., 2018) Among the types of drugs
prescribed to treat PTSD, some common ones are:

 Antidepressants:
o Selective Serotonin Reuptake Inhibitors (SSRIs); Selective
Norepinephrine Reuptake Inhibitors (SNRIs); Monoamine Oxidase
Inhibitors (MAOIs)

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  Antipsychotics and A-typical Antipsychotics

 Benzodiazepines:
o Alprazolam (Xanax), Diazepam (Valium), Clonazepam (Klonopin)

Antidepressants in particular have been shown to mitigate several symptoms of PTSD, and have
proven to assist with the treatment of PTSD in randomized-controlled trials when compared to
placebo. (Sullivan and Neria, 2009)

Antipsychotics have not proven as well on their own: “Overall there is little empirical evidence
supporting use of atypical antipsychotics as monotherapy in PTSD, and data on use as an
augmentation strategy to SSRIs is equivocal.” (Sullivan and Neria, 2009)

Benzodiazepines have had surprisingly few studies conducted regarding their effectiveness in the
treatment of PTSD. In fact, in the one study I could find the authors concluded that, “Symptoms
specific to PTSD were not significantly altered.” (Braun, et al.)

Figure 3: Pharmacological medication recommendations for pharmacotherapy treatment of PTSD according to

Neuroscience research at Rutgers University. Source: Brain Alliance of New Jersey, 2016

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Figure 4: Pharmacological medication recommendations for pharmacotherapy treatment of PTSD according to
Neuroscience research at Rutgers University. Source: Brain Alliance of New Jersey, 2016

The danger with some of these medications is even when they are effective, they rarely produce
zero side effects. According to Harvard Health online medical journal, among the most common
antidepressant side effects are sexual problems, weight gain, feeling emotionally numb/distant,
increased feelings of sadness, caring less about other people, and suicidal thoughts. (Harvard
Health, 2019)

Apart from side effects, these medications can be toxic if they’re mixed improperly, if they’re
combined with alcohol or other recreational drugs, and when they’re not taken in proper
intervals—which is especially dangerous, as stopping cold-turkey dramatically increases the risk
for suicide.

3 MDMA-Assistive Psychotherapy
MDMA (3-4 Methylenedioxymethamphetamine) is a psychoactive stimulant developed by
MERCK pharmaceuticals in 1912. MDMA experienced brief therapeutic use in the 1950s and
60s. However, responding to an outbreak in recreational usage, the DEA parked it the list of
controlled substances as a Schedule-I drug in 1985. Until recently, the only evidence supporting
MDMA has been largely anecdotal, as it has not been researched or deemed appropriate for
medical use.

6
In 2010, MAPS (Multidisciplinary Association for Psychedelic Studies) began researching the
therapeutic potential of MDMA-assistive psychotherapy in controlled trials on a group of
volunteers diagnosed with PTSD. MDMA is used as only part of the healing process, and works
to enhance the effectiveness of typical psychotherapy for those receiving treatment for PTSD.

Figure 5: Therapeutic dose of MDMA for MAPS Phase II Clinical Trials. Source: MAPS, 2014

Regular pharmacotherapy requires long-term daily medicating that will often numb the
symptoms of PTSD without addressing the disorder directly; MDMA-assistive psychotherapy
treatment lasts only 10 weeks, directly addresses the psychological root of the disorder, and
allows the patient to encounter the trauma-memory without the cognitive fear-response
associated with the traumatic event.

MAPS is currently the only association publicly spearheading research on MDMA-assistive

psychotherapy in the United States. According to their website, “On July 28, 2017, MAPS and
the FDA reached agreement on the Special Protocol Assessment for Phase 3 clinical trials. This
agreement confirms that that the protocol design, clinical endpoints, planned conduct, and
statistical analyses for the Phase 3 trials are acceptable to support regulatory approval by the
FDA.” (MAPS, 2019) This is huge in terms of legislation, as they have bene seeking FDA-
approval since 1986. This could mean big things for MDMA-assistive psychotherapy in the near-
future. If all goes according to MAPS founder Rick Doblin’s projections, the United States could
start seeing psychedelic clinics pop up by the early 2020s. According to their website, “MAPS is
undertaking a roughly $26.9 million plan to make MDMA into a Food and Drug Administration
(FDA)-approved prescription medicine by 2021.” (MAPS, 2019)

Progress on a federal-level would not be possible without powerful evidence to support

MDMA’s medicinal/therapeutic value. MAPS has already conducted two phases of randomized
placebo-controlled clinical trials showing incredible results for MDMA’s therapeutic potential
when combined with psychotherapy. (MAPS, 2019)

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3.1 Maps Phase I & II Clinical Trials

Figure 6: MAPS MDMA-Assistive Psychotherapy Treatment Structure and Results. Source: MAPS, 2014

The most recent Phase II Clinical trials, which ended in 2016, were conducted in this manner:
Subjects were administered either MDMA or placebo during two, eight-hour sessions conducted
3-5 weeks apart, along with weekly psychotherapy sessions. The subjects administered MDMA
or placebo had been living with PTSD for upwards of 20 years. The results between the placebo-
groups and the MDMA-administered group are extremely promising. (MAPS, 2019)

8
 After three psychotherapy sessions with MAPS therapists, the treatment-resistant placebo-control
group experienced a 23% success rate in the treatment of PTSD symptoms two-months post-
treatment. The MDMA-administered group experienced a 61% success rate in PTSD symptoms
two-months post treatment. A full year after treatment, the MDMA-administered group reported
a 68% recovery rate. 3.8 years post-treatment, the MDMA-administered group continues to
report that the benefits of MDMA-assistive psychotherapy have been maintained over time.
(Hausfield, 2019)

Figure 7: MAPS MDMA-Assistive Psychotherapy Treatment Phase II Clinical Trial Results. Source: MAPS, 2016

Despite the Phase II trials being conducted with only a few hundred participants, the results are
undeniably promising. They show that given the proper therapeutic setting, guidance, and
education, MDMA-assistive psychotherapy is a safe and incredibly effective treatment option for
those healthy enough to participate.

3.2 MAPS Phase III Clinical Trials

In 2016, MAPS presented all of their data to the FDA and were approved to begin Phase III
clinical trials of MDMA-assisted psychotherapy for PTSD. Along with the trial approval, the
FDA entered into a binding agreement with MAPS stating that the FDA will begin approving
prescriptions for MDMA-assisted psychotherapy if Phase III trials obtain the same statistically-
significant results and show no new safety concerns. (Hausfield, 2019)

9
According to MAPS website, “Phase 3 trials will take place at 14 research sites in the U.S.,
Canada, and Israel. Participants in the main portion of the trial will be randomized to receive
three sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week
treatment period, along with non-drug preparatory and integration sessions (three each).”
(MAPS, 2019) The Phase III trials follow similarly from the Phase II trials, except this time with
three doses of MDMA being administered three to five weeks apart. (MAPS, 2019)

If the results from Phase III trials mimic the results from Phase I and II, we could easily start
seeing MDMA-assistive psychotherapy being prescribed by the early 2020s.

4 Challenges to MDMA-Assistive Psychotherapy

Historically, the challenges posed to MDMA-assistive psychotherapy have been strictly
legislative. Since MDMA is a Schedule-1 controlled substance, it is extremely hard to get federal
approval for research. As MAPS is currently the only organization approved for research on
MDMA-assistive therapy, most of the research surrounding the therapeutic potential for MDMA
comes from them. However, if all goes according to MAPS projections and Phase III trials
indeed show promising results, it could spark a new wave of research accessibility for a larger
audience.

So far, the challenges stem from what happens after MDMA-assistive psychotherapy is approved
for prescription. Because MPAS is the only organization this close to gaining FDA approval,
they will hold all the cards as to how efficient the progression of MDMA-assistive therapy into
the socioeconomic zeitgeist will be. If clinics are to begin to pop up around the United States,
there need to be enough MAPS-trained therapists to supplement them, and because this treatment
is so new and specialized, it is also going to be expensive. According to MAPS founder Rick
Doblin, Phase III MDMA treatment protocols call for twelve sober therapy sessions, with three
MDMA sessions; a total between 42-60 hours of treatment. (Hausfield, 2019) It’s projected that
initial costs for treatment with MDMA-assistive psychotherapy could run around $15,000.
(Hausfield, 2019)

MAPS is currently in communication with insurance companies about expanding coverage to

include MDMA-assistive psychotherapy, which would drastically increase the affordability and
accessibility of treatment to a more diverse population. (Hausfield, 2019)

5 Conclusion

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Simply put, PTSD is a debilitating disorder affecting thousands of veterans in the United States,
that if left unchecked can lead to severe psychosocial issues and suicide. PTSD has high
healthcare costs and and current psychotherapy treatments like Prolonged Exposure Therapy and
Cognitive Processing Therapy have proven to be effective at treating the root psychological
trauma of PTSD, but often experience high patient drop-out rates. When it comes to long-term
treatment of the disorder, the effects of psychotherapy alone are not always reliable. Current
models also rely on pharmaceutical intervention, which is problematic on two levels: this keeps
the patient tethered to the drug, or rather to the pharmaceutical company, for (sometimes) the rest
of their life; the drugs used to treat PTSD are often effective at alleviating symptoms of the
disorder, but do not address the root psychological trauma whence the disorder stems. This
creates lots of new pharmaceutically-reliant patients, but a low number of those that actually
recover.

MDMA-assistive psychotherapy is an emerging kind of treatment that combines MDMA and

psychotherapy to tackle the root psychological trauma feeding the disorder. Unlike previous
models of care, MDMA-assistive psychotherapy is completed in as little as ten weeks. Currently,
research is being spearheaded by MAPS, whose results from Phase II clinical trials show a 61%
decrease in PTSD qualification symptoms two months after one-round of MDMA-assistive
psychotherapy treatment. Compare that with a 23% decrease two months after one round of
placebo and psychotherapy treatment. After one year the MDMA group’s number rose to 68%;
3.8 years post-treatment, that number has risen still.

Due to compromising legislation, there hasn’t been much research on the therapeutic benefits of
MDMA since the 1960s; now all of that is rapidly changing. If MAPS Phase III clinical trial
results follow their projections, MDMA-assisted psychotherapy clinics could start opening
around the United States by the early 2020s. Upon FDA-approval for prescription, the initial
socioeconomic hurdle of making MDMA-Assisted Psychotherapy both affordable and accessible
to a diverse population of peoples will be the next big challenge. Large-scale socioeconomic
change does not happen overnight—especially when federal legislation is evolved. However,
with the majority of patients who received MDMA-assistive psychotherapy having recovered at
remarkable rates (and still rising post-treatment), I think MDMA-Assistive Psychotherapy is the
future for treating PTSD in the United States.

11
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