Patchwork Art from MAPS Therapist Training Program 2017
Photo Credit: Alyssa Gursky
Findings from the last study in a series of six Phase 2 trials of MDMA-assisted psychotherapy for treatment of posttraumatic stress disorder (PTSD) was published today in the Journal of Psychopharmacology . The clinical trial in Boulder, Colorado (MP-12) enrolled 28 participants suffering from chronic PTSD. Results showed that after two to three sessions of psychotherapy with active doses of MDMA (100-125 mg) PTSD symptoms were markedly reduced. Twelve months later most participants (76%) did not meet criteria for PTSD.
After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges.
Marcela Ot’alora G.
Principal Investigator Boulder, CO
Decades in the Making
The Multidisciplinary Association for Psychedelic Studies (MAPS) was founded in 1986 with the intention to take MDMA through the FDA-regulated drug development pipeline. The non-profit organization faced many political and logistical hurdles to research MDMA, a schedule 1 controlled substance. The first randomized, blinded study investigating MDMA-assisted psychotherapy started in 2000 in Spain by MAPS. After treating six women survivors of sexual assault with no serious adverse effects and PTSD symptoms on decline, the study was suddenly halted due to political pressure from the Madrid Anti-Drug Authority in 2002 .
Marcela Ot’alora G., MA, LPC was a psychotherapist in this first study. A decade later in 2012 she became the first woman Principal Investigator for a MAPS-sponsored trial in the US. She trained and supervised nine therapy teams for the trial in Boulder, and treated 17 participants as the lead psychotherapist. Importantly, the positive results from this study showed that new therapy teams could replicate findings from previous studies (MP-1 , MP-8 ) that had a single therapy team – Michael Mithoefer, MD (Psychiatrist) and his wife Annie Mithoefer, BSN (Psychiatric Nurse). It was uncertain if interns and newly trained therapists would be able to produce significant results equivalent to the very experienced and compatible Mithoefer team.
PTSD Symptoms Improve
The 100 mg and 125 mg doses had a medium to strong effect on PTSD symptoms, but only the per protocol set reached significant group differences at this point. Principal Investigator Marcela Ot’alora G. commented, “The results of the study indicate that this treatment has the potential to greatly improve the lives of people suffering from PTSD, regardless of the source of their trauma”. At this point, a month after both blinded sessions, participants learned what dose group they were in. Participants given 100 and 125 mg had a third open label session, and participants given 40 mg started a new, second part of the study, or a “cross-over” where they had three open-label MDMA sessions.
“After treatment, a great majority of our participants have reported feeling more connected to themselves and to others, more joy, more compassion, and with new skills for facing life’s challenges” explained Marcela.
Based on the positive safety and efficacy outcomes from this trial and the other similar Phase 2 studies, FDA granted Breakthrough Therapy Designation for this innovative treatment approach. Breakthrough Therapy is only given for drugs under development that have data indicating that they work better and/or more safe than current medications for a life-threatening illness. This designation is intended to speed up timelines in the path to FDA approval.
Though originally planned to start earlier, Phase 3 trials will start in November 2018 due to unforeseen delays with producing and encapsulating Good Manufacturing Practices (GMP) MDMA. If two trials have significant outcomes in 200-300 participants, MDMA-assisted psychotherapy could be an FDA-approved treatment by 2021.
What we see after reprocessing of memories and feelings is not only reduction in PTSD symptoms but improvement in other areas of their lives, including mood and sleep.
Dr. Lisa Jerome
MAPS PBC Researcher
In preparation for Phase 3 trials in the USA, Canada, Israel, and Europe, the MAPS Therapy Training Program has expanded to meet the need for well-trained therapists at new study sites. Therapists in this program are trained on the MDMA Treatment Manual, which was first authored by Michael Mithoefer and updated regularly as the therapeutic approach is fine-tuned.
Marcela is a lead trainer, along with the Mithoefers, and brings her passion for art to the training program. She teaches trainees about how art can be used as a non-verbal expression of internal processes and offers ways to bring art into therapy sessions during and after altered states of consciousness.
The Phase 3 MAPS Therapy Training Program consists of online e-learning modules, reading assignments, a 7-day in-person training to watch and discuss MDMA psychotherapy videos from completed studies, a 5-day in-person meeting for team building and role play, and supervision during an open-label Phase 2 MDMA study. The program will continue to scale and adapt to accommodate more trainees interested in providing MDMA therapy in Expanded Access and post-approval psychedelic clinics.
Boulder, CO will be one of approximately 15 study sites in the Phase 3 trials. Enrollment of new participants will start in November 2018. Visit maps.org for more information about study participation, therapist training, and research updates.
- Ot’alora, G., Marcela, Jim Grigsby, Bruce Poulter, Joseph William Van Derveer III, Sara Gael Giron, Lisa Jerome, Allison A. Feduccia, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C. Mithoefer, Rick Doblin. “MDMA-assisted psychotherapy for Treatment of Chronic Posttraumatic Stress Disorder: A Randomized Phase 2 Controlled Trial.” Journal of Psychopharmacology. (2018). Full article link.
- Bouso, José Carlos, Rick Doblin, Magí Farré, Miguel Ángel Alcázar, and Gregorio Gómez-Jarabo. “MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder.” Journal of Psychoactive Drugs. 40, no. 3 (2008): 225-236.
- Mithoefer, Michael C., Mark T. Wagner, Ann T. Mithoefer, Lisa Jerome, and Rick Doblin. “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, no. 4 (2011): 439-452.
- Mithoefer, Michael C., Ann T. Mithoefer, Allison A. Feduccia, Lisa Jerome, Mark Wagner, Joy Wymer, Julie Holland et al. “3, 4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.” The Lancet Psychiatry. 5, no. 6 (2018): 486-497.