MAPS Announces Findings from Phase 2 MDMA Clinical Trials for PTSD
This week, the Multidisciplinary Association for Psychedelic Studies (MAPS) published new evidence to support MDMA-assisted psychotherapy’s lasting benefits for PTSD. An investigation on the long-term, follow-up outcomes of six phase 2 clinical trials of MDMA-assisted psychotherapy revealed that the majority of participants experienced lasting benefits for at least 12 months after their last treatment session. The six controlled, randomized, double-blind trials were carried out over the course of 13 years, from 2004 to 2017.
In their announcement about the trial results, MAPS said that 56% of 100 participants “no longer met the diagnostic criteria for PTSD” after two months since their last session, a percentage that increased with time. After 12 months, 91 participants were interviewed, of which 67% did not qualify for a PTSD diagnosis, according to researchers. The most common adverse effect reported was “worsened mood,” experienced by less than 4% of the study’s participants.
Trauma research is more relevant than ever, given the intense challenges faced globally this year. In the announcement, Berra Yazar-Klosinski, Ph.D., paper co-author and Deputy Director and Head of Research Development and Regulatory Affairs at MAPS, says that trauma is at the “forefront of global consciousness” due to the pandemic, as well as increasing awareness around systemic oppression.
“This is the breakthrough that the world needs right now,” says Yazar-Klosinski.
While the results bode well for the future of PTSD treatment, they lack racial diversity, something that MAPS and its Public Benefit Corporation, which conducts their research, have been actively working on for the last two years. Nearly 90% of the 107 participants were white/Caucasian, and the therapists working on the Phase 2 studies were “predominantly white, which reflects the broader U.S. workforce of psychologists,” Yazar-Klosinski told Lucid News.
One of the potential reasons for this overwhelming disparity was that MAPS lacked the funding in Phase 2 to provide financial assistance to study participants. “As a result, most of the participants were more likely to be able to take off work,” explains Yazar-Klosinski. Now that MAPS is in Phase 3, they’re able to provide direct financial support to participants who might need it.
Financial support, however, has only resulted in “incremental change” due to a number of key systemic challenges. Disparities in access to mental health treatments and the stigma of taking an “illegal” drug by a group of people who have been more frequently incarcerated for drug use are contributing factors. The critical factor that needs to be addressed going forward, according to Yazar-Klosinski, is inviting and training more therapists of color into their MDMA Therapy Training Program, which MAPS Public Benefit Corporation is currently working on.
“We are committed to ensuring those who are underserved by our current healthcare system can participate in psychedelic therapy clinical trials,” says Yazar-Klosinski. “We still have a long way to go, and we are listening and doing what we can.”
The newly released paper is the most comprehensive analysis of the safety and durability of MDMA-assisted psychotherapy treatment outcomes to date.
Image by Tim Mossholder
