Treating PTSD with MDMA 1

Running Head: Treating PTSD with MDMA

Treating Post-Traumatic Stress Disorder with MDMA Assisted Psychotherapy:

A New Understanding of Ecstasy
Cameron W. Carpenter
Sarah Lawrence College

Treating PTSD with MDMA 2

Treating Post-Traumatic Stress Disorder with MDMA Assisted Psychotherapy:
A New Understanding of Ecstasy
For decades now, MDMA has been ignored by the psychiatric community; written off as
a club drug with no therapeutic benefits. However, due the rising rates of conditions that do not
response to current medication or therapeutic techniques, such as post traumatic stress disorder
(PTSD), more and more researchers, practitioners, and people in general are beginning to think
the answer to this problem might lie not in some medication that has yet to be developed, but in
an old one long since overlooked. This paper will demonstrate the safety and efficacy of
undergoing psychotherapy while under the influence of pharmaceutical-grade MDMA as a
treatment for PTSD.
Before exploring MDMAs therapeutic potential, it is necessary to give some background
information on the drug to clear up any misunderstanding. MDMA (3,4methylenedioxymethylamphetamine) is often believed to be a relatively new substance, however
that is not the case. While it did not gain recreational popularity until the 1980s, MDMA was
patented in 1912 by the Merck pharmaceutical company for use as a precursor to an
antihemorrhagic agent. Its psychoactive properties were not discovered until 1978, when
researchers Sasha Shulgin and Dave Nichols published a study of the drugs effects on humans
(Holland, 2001, pg. 11-13).
Dr. Shulgin believed the compound showed great promise as an aid in psychotherapy, and
began recommending and supplying it to practitioners. At this time, MDMA was not yet on the
radar of the FDA or the DEA. Therefore, even though it was not an approved prescription
medicine, it was not illegal to manufacture, possess, distribute, or administer. From 1978 until
1985, more and more psychiatrists who had connections to Shulgin began practicing MDMA

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assisted psychotherapy. Since Shulgin and his colleagues were trying to keep their activities
under wraps, hard data and meticulous records of the drugs efficacy and safety from this period
are almost nonexistent. However, anecdotal reports claim that, due to the emotional openness
and greatly diminished fear response, undergoing psychotherapy while under the influence of
MDMA is a very successful treatment method. It is estimated that over a thousand MDMA
assisted therapy sessions were performed in total over those seven years (Holland, 2001, pg. 1113).
Dr. Shulgin and his colleagues did their best to keep MDMA within the confines of
laboratories and clinical settings, fearing that recreational use of the substance would doom it to
the same fate LSD suffered just a decade earlierbecoming a Schedule I narcotic. Schedule I is
the most restrictive drug class, reserved for substances that have a very high potential for abuse
and no accepted medical value. Unfortunately, that is exactly what happened. By the early 80s,
MDMA had become a popular club drug, sold in the form of pressed pills that went by the name
ecstasy. In 1985, the DEA used their emergency scheduling power to immediately place
MDMA in Schedule I for one year. The following year, the DEA went to federal court to prove
that MDMA had no medicinal value, in order to keep it in Schedule I permanently. This attempt
failed, and the judge ruled that MDMA be moved down to Schedule III, which would allow
researchers to continue studying it, and practitioners to continue utilizing it. However, congress
gave the DEA the power to overrule the courts decision and keep MDMA locked up in the
Schedule I vault, which of course they did (Holland, 2001, pg. 13-15).
Currently, there is only one organization sponsoring clinical trials with the goal of getting
MDMA rescheduled and approved by the FDA as a prescription medicationa small, nonprofit
research group known as MAPS, or the Multidisciplinary Organization for Psychedelic Studies.

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In an article published in 2002 in the Journal of Psychoactive Drugs, Dr. Rick Doblin, founder
and executive director of MAPS, discusses why he believes that MDMA assisted psychotherapy
is a viable treatment option for post traumatic stress disorder (PTSD).
First, a bit of background information from the National Center for PTSD (2015):
Approximately seven to eight percent of the United States population will meet the diagnostic
criteria for PTSD at some point in their lives. The symptoms of this disorder include flashbacks
of one or more traumatic events with or without a trigger (e.g. a car backfiring), night terrors,
insomnia, anxiety/panic attacks, self-destructive behavior, dissociation, and paranoia. To meet
the criteria for PTSD, these symptoms have to last longer than three months and/or significantly
impair ones ability to function. Many patients do not respond to cognitive behavioral therapy,
exposure therapy, or medication. At the moment, there are only two drugs approved by the FDA
for the treatment of PTSDsertraline (Zoloft) and fluoxetine (Prozac), both of which are
selective serotonin reuptake inhibitors (SSRIs). Of course, other medications such as
benzodiazepines and antipsychotics are also prescribed off-label to patients with PTSD. While
the SSRIs were shown to be more effective than a placebo, many patients with chronic PTSD do
not find relief from these or any other prescription drugs. It appears that traditional methods of
treatment, while effective for some, are not effective in a large segment of the population with
PTSD.
Dr. Doblin believes MDMA assisted psychotherapy may be the answer for those suffering
from treatment-resistant PTSD. One huge advantage MDMA has over treatments such as SSRIs
is that it would only be administered in an inpatient settingas apposed to writing a prescription
for a months supply of medication and instructing the patient to dose themselves daily, a doctor
would simply provide the dose for the session, and that would be that. Retail pharmacies

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wouldnt stock it, since it wouldnt be prescribed for outpatient treatment. In other words,
MDMA would never leave the doctors office. The potential for having a disturbing experience
while under the influence of MDMA is extremely low, due to its powerful anxiolytic effects and
the overall sense of well being that the drug produces. The cognitive impairment caused by
MDMA is negligible compared to that of hallucinogensincluding marijuanaor even alcohol.
MDMA is not so much a consciousness-altering drug as it is an emotion-altering one. The
primary psychological effects of MDMA are a marked increase in empathy, a strong sense of
emotional security, a greatly reduced fear response, increased feelings of self-confidence/selfworth, and an enhanced ability to connect with, understand, and communicate to others ones
own emotional state. One can easily understand how being under the influence of MDMA
during a therapy session could lead to exponential progress in treating PTSD (Doblin, 2002).
While MDMA assisted psychotherapy may have the potential to treat a wide variety of
disorders, MAPS is being careful not to bite off more than they can chew. As shown in 1986, the
DEA is not afraid to fight dirty when it comes to rescheduling drugs. Dr. Doblin has made the
strategic choice to focus only on getting MDMA approved to treat PTSD for the time being.
There are two major reasons why. First of all, if MAPS succeeds in getting MDMA approved for
just one condition, then itll be automatically moved down to Schedule II, the category for drugs
with a high potential for abuse but a federally accepted medical value. If that happens, MAPS
and any other interested organizations will be able to study MDMA for the treatment of many
other conditions without all the red tape that comes with conducting research into a Schedule I
narcotic (Doblin, 2002).
The second reason Doblin chose PTSD was that it was the most likely disorder to have
the most immediate and most significant positive response to MDMA. While genetics do play a

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role in ones likelihood of developing PTSD after a traumatic event, the disorder has a clearly
external causethe trauma, and more importantly, the memory of said trauma. This gives the
therapist something specific to target and work on with the patient during the session. The
hypothesis behind MDMAs potential as a treatment for PTSD hinges on the fact that our
autobiographical memories are malleableevery time one recalls something from their past,
they are actually using their imagination to reconstruct the situation, their current emotions and
thoughts unintentionally altering the memory in the process. Under normal circumstances, these
alterations are so insignificant that we rarely, if ever, notice them. However, since MDMA has
the unique quality of drastically decreasing ones fear response while leaving them relatively
clear-headed, if a patient who had developed PTSD after, say, being assaulted, were to describe
the assault in detail to their therapist while under the influence of MDMA, the idea is that the
feeling of emotional safety and serenity induced by MDMA would cause the memory to be
reconstructed in such a way that greatly reduced or even erased the negative emotions, especially
fear, associated with it (Doblin 2015). According to an article published in the British Journal of
Psychiatry, magnetic resonance imaging . . . showed that MDMA reduced amygdala and
hippocampus activity and selectively attenuated the magnitude of negative memories (Sessa &
Nutt, 2015).
The results of the first pilot study assessing the efficacy and safety of MDMA assisted
psychotherapy were published by Michael C. Mithoefer, Mark T. Wagner, Ann T. Mithoefer, Lisa
Jerome, and Rick Doblin in 2011 in the Journal of Psychopharmacology. The study was
conducted with twenty participants total, seventeen women and three men. Of that twenty,
twelve were given MDMA and eight were given an inactive placebo. The subjects were
randomly placed into one of the two groups, and the study was conducted in a double-blind

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fashion, meaning neither the therapists nor the participants knew who was in the control group or
the experimental group. The first stage of the experiment involved two nondrug introductory
sessions with the two psychiatrists, one male and one female, who would be working with them
during the experience. Following that, two MDMA/placebo experimental sessions were
conducted. The subject received either 125 milligrams of MDMA or placebo, with an optional
additional dose of 62.5 milligrams of MDMA or placebo after two hours. The practitioners
stayed with the subject for eight hours, alternating between conversing with them and allowing
them to focus on introspection in silence or with music in the background. The participants
stayed at the clinic overnight with a psychiatric nurse on duty, and then had a nondrug session
with the same psychiatrists the next morning. Daily phone consultations were conducted with
the subject for seven days after the session. This entire process was done for each subject
individually. Once stage one was completed, the blind was broken and the results were analyzed.
For stage two, those who received a placebo were given the option to go through the above
process again, this time with MDMA.
The results were very promisingin stage one, ten out of the twelve participants in the
MDMA groupeighty-three percentno longer met the DSM-IV criteria for a diagnosis of
PTSD two months after their final experimental session. In the control group, six of the eight
participants still suffered with PTSD, a clinical response of only a quarter. Those six all elected
to participate in stage two, as well as one of the two placebo-response subjects who had a relapse
of symptoms. All seven of the participants in stage two no longer met the criteria two months
after their final MDMA sessiona one hundred percent clinical response.
There were no serious adverse responses, and none of the subjects required medical
intervention during any of their experimental sessions. The most common side effects while

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under the influence of MDMA were: Tightness in the jaw, dizziness and impaired balance,
nausea, headache, reduced appetite, minor anxiety at the beginning of the experience, chills, and
insomnia. Seven days after the experimental sessions, the most common lingering side effects
were: Anxiety, insomnia, irritability, low mood, fatigue, headache, nausea, and a decrease in
appetite. Most subjects found that the side effects faded away on their own after a few days,
although some participants opted for short courses of sedative hypnotics to treat the resulting
insomnia, and over-the-counter pain relievers such as ibuprofen for headaches.
Neuropsychological testing found no evidence of any lasting impairment in cognitive function in
any of the subjects. Considering the fact that this list of side effects is almost identical to that of
many commonly prescribed psychotropic medications, such as SSRIs and stimulants, and
considering the effectiveness of the treatment, it appears from this study that not only is MDMA
a useful adjunct to psychotherapy, but a safe one as well.
Three and a half years after this pilot study was completed, a long-term follow-up
(LTFU) study was completed by the same research team with the same participants, the goal
being to gage the endurance of the benefits from MDMA assisted psychotherapy, as well as the
potential lasting negative effects and risk of subsequent illicit drug use. This was assessed via a
questionnaire designed by the researchers as well as phone consultations with the subjects. The
results of this study are even more optimistic than that of the originalout of the nineteen
participants who had received MDMA during either phase one or two of the pilot study,
seventeen reported lasting benefits from the treatment, while two reported a relapse in PTSD
symptomsa long-term clinical response rate of eighty-nine percent. On a scale of one to five
one being slight overall benefit, five being large overall benefiteleven out of the nineteen
responded with five, while none of the participants responded with less than two. Rating the

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degree to which the benefits lasted using the same scale, a plurality of the subjects (eight out of
nineteen, forty-two percent) responded with five (benefits lasted and continued to grow), while
again none of the participants responded with less than two. Even the two subjects who reported
a relapse in symptoms still found that the treatment had a lasting positive effect on them. Pretreatment, sixteen subjects were undergoing psychotherapy. At the time of the LTFU study, only
eight had continued with said therapy. The number of participants taking psychiatric
medications (twelve) did not change in the time between pre-enrollment and the LTFU study,
although the mean number of medications being taken dropped from 1.7 to 1.3, a negligible
decrease (Mithoefer et. al, 2012).
All of the subjects answered no to the question Do you feel you were harmed by
participation in the study? and yes to the question Do you believe more MDMA sessions
would have been helpful? When asked about cognitive function, memory, and concentration,
seven of the participants reported no change, while twelve reported improvements in these areas.
When asked about illicit drug use post-treatment, eight subjects reported using marijuana, with
frequency ranging from once to occasionally. One subject reported using psilocybin mushrooms,
but did not report the frequency. All of the participants who reported using these substances had
reported usage of these drugs before being enrolled in the pilot study. One of the subjects
reported using ecstasy once after the treatment. The subject had attempted to recreate the
therapeutic setting by consuming the drug in their home in the presence of a close friend. The
subject did not find this to be a worthwhile endeavor, and reported no desire to consume MDMA
outside of a legal, medical setting (Mithoefer et. al, 2012). While this study is limited by the fact
that it relied upon the self-assessment of the participants, the fact that every single one of the
nineteen subjects, even the two who had suffered a relapse of symptoms, reported lasting

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benefits after participating in the pilot study, coupled with the absence of any long-term negative
effects, demonstrates that MDMA assisted psychotherapy is a promising treatment for PTSD.
After the success of this pilot study, the FDA approved MAPs request to move on to
Phase 2 clinical trials to study the effects of MDMA assisted psychotherapy on a much larger
body of patients with treatment-resistant PTSD (Doblin 2015). In January 2016, the last
participant in the closing study received their final dose, thus concluding the experimental side of
the Phase 2 trials. The data from these studies is currently being analyzed, and MAPS is in talks
with the FDA to design Phase 3 clinical trials, which will involve hundreds of subjects all over
the globe. Phase 3 is the last experimental phase required by the FDA before a drug can be
approved as a prescription medication. MAPS is hoping to begin these trials by early 2017, with
the goal of making MDMA assisted psychotherapy an FDA-approved treatment for PTSD by
2021 (MAPS, 2016).
It may seem quixotic to think that MDMA will be available as a prescription medication
in just five years, but consider thisonly a decade ago, Dr. Doblin and the research team at
MAPS were hard at work trying to overcome twenty years of stigma and harsh legislation in
order to gain approval to carry out the pilot studies described earlier. It is nothing short of
astounding that one small nonprofit has single-handedly come so far towards changing the
cultural attitude and legal restrictions surrounding MDMA in such a short period of time. Taking
into account the success of the pilot studies, as well as the speed with which the Phase 2 trials
were carried out, five years doesnt seem so unrealistic.
Only time will tell, but one things for sureMAPS iron-clad will, unshakeable
optimism, and brilliant strategic moves have already changed the landscape of psychiatry and
drug legislation forever and for better. No drug has ever been moved out of Schedule I to date,

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but MDMA is now far closer than any other. Dr. Doblin and MAPS deserve sole credit for this,
as they were the first to see the diamond in the ruff in the worlds most notorious club drug, and
the only ones with the courage and determination to undertake the bold feat of legitimizing and
scientifically documenting the healing potential of MDMA. At its heart, this is a David and
Goliath storyone nonprofit against the seemingly invincible War on Drugs.
If MDMA does get approved as a treatment for PTSD, it will be the proverbial stone that
takes down Goliath. As mentioned earlier, in granting MDMA prescription status, it will
automatically be moved down to Schedule II. That will make doing research with the drug
infinitely easier, and pave the way for the rescheduling of other substances with therapeutic
potential that are locked up in Schedule I, such as marijuana, LSD, and psilocybin. Dr. Doblin
has high hopes for a post-MDMA approval future. At a presentation in San Francisco in 2015,
he outlined a few of the projects he has in mind. The list includes treating social anxiety in
autistic adults with MDMA assisted psychotherapy, using LSD assisted psychotherapy to help
those suffering with anxiety after being diagnosed with a terminal illness, and treating addiction
with psilocybin assisted psychotherapy.
It is no coincidence that every proposed treatment mentioned above involves drug
assisted psychotherapy. In fact, the only substance that MAPS believes has value as an
outpatient treatment is marijuana. Every other drug only has value when used as an adjunct to
psychotherapy, meaning that, in the same vein as MDMA, psychedelics would only be
administered under a psychiatrists supervision, and might only be given to the patient a few
times. This is radically different from the way medications such as SSRIs are used, where a
patient takes the drug every day for months, years, or in some cases an entire lifetime. MDMA
and psychedelics, no matter what disorder theyd be treating, would be utilized for their short-

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term effects, and would only be dispensed in an inpatient setting. One can see the obvious
advantage a medication that need only be taken a handful of times has over a medication that
requires daily self-dosing for extended periods. This method of administration is as much a
paradigm shift as the usage of the drugs themselves.
While these might be the same substances endorsed by the tune in, turn on, drop out
pseudo-psychologists of the 1960s (who are as much to blame for the harsh scheduling of these
compounds as the DEA), Dr. Doblin and the MAPS research team are about as far from
Woodstock as you can gettheyre serious academics with a rigorous agenda who hate to see
these drugs abused as much as the government does. They advocate for responsible, controlled
research into and medical use of substances that have great therapeutic potential.
If MDMA does becomes a prescription drug, than its potential will be utilized and
explored to the fullest extent. Whats more, it will prove that Schedule I is not impenetrable, and
that shifts in cultural mindsets regarding drugs are in fact possible. That will exponentially
increase the already-building momentum behind the movement to reopen research into
psychedelics and marijuana. Except, this time, said research will be in the hands of the right
people, and the healing potential of these substances which have been demonized for so long will
be explored safely for the advancement of psychiatry. As a nation, we have learned from the
mistakes of the 60s. Now its time to realize that the pendulum has swung too far. If anyone
can bring about this change in the American mindset, its Dr. Doblin and the research team at
MAPS.
References

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Doblin, R. (2002). A clinical plan for MDMA (ecstasy) in the treatment of posttraumatic stress
disorder (PTSD): Partnering with the FDA. Journal of Psychoactive Drugs, 34(2), 18594. Retrieved from http://search.proquest.com/docview/207974658?accountid=13701
Doblin, R. (2015). Book Launch Event: Modern Consciousness Research and the Understanding
of Art, by Stanislav Grof. Presentation, San Francisco.
Holland, J. (2001). Ecstasy: The Complete Guide. Rochester, NY: Park Street Press.
MAPS Newsletter. (2016, March 11). Retrieved March 21, 2016, from
http://www.maps.org/news/update
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., & Doblin, R. (2010). The safety
and efficacy of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects
with chronic, treatment-resistant posttraumatic stress disorder: The first randomized
controlled pilot study. Journal of Psychopharmacology, 25(4), 439-452. Retrieved March
2, 2016, from http://jop.sagepub.com/content/25/4/439.short
Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., Martin, S. F., Yazar-Klosinski,
B., . . . Doblin, R. (2012). Durability of improvement in post-traumatic stress disorder
symptoms and absence of harmful effects or drug dependency after 3,4methylenedioxymethamphetamine-assisted psychotherapy: A prospective long-term
follow-up study. Journal of Psychopharmacology, 27(1), 28-39. Retrieved March 2,
2016, from http://www.mdmaptsd.org/images/research/mithoefer_etal_2012_ltfu.pdf
PTSD: National Center for PTSD. (2015, September 1). Retrieved February 26, 2016, from
http://www.ptsd.va.gov/public/PTSD-overview/basics/index.asp

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Sessa, B., & Nutt, D. (2015). Making a medicine out of MDMA. The British Journal of
Psychiatry, 206(1), 4-6. Retrieved February 24, 2016, from
http://bjp.rcpsych.org/content/206/1/4.full.pdf html?#sec-3