New results from a clinical trial into the efficacy of MDMA-assisted psychotherapy in treating PTSD have revealed incredible rates of success, with 76 percent of subjects not meeting the criteria for PTSD a year after receiving treatment.
This study is one of six Phase 2 clinical trials used to convince the FDA to grant MDMA-assisted treatment a Breakthrough Therapy Designation. This trial, sponsored by MAPS, the Multidisciplinary Association for Psychedelic Studies, was conducted by psychotherapist Marcela Ot’alora in Boulder, Colorado.
28 subjects participated, all diagnosed with PTSD that had persisted for an average of almost 30 years. The subjects PTSD had persisted despite attempts with other conventional treatments, including drugs and psychotherapy. The treatment followed the model established by MAPS in other trials. The MAPS model is two day-long MDMA treatment sessions followed by integrative therapy sessions. A third session is also offered to evaluate whether it improves long-term responses compared to two sessions.
Treatment evaluations were done using the current best standard for PTSD assessment the CAPS-IV. On enrollment, the average CAPS-IV score of each participant was 92, and on follow-up a year after the final MDMA session, the average CAPS-IV score was just 31. After 12 months 76 percent of participants did not meet the clinical diagnostic criteria for PTSD.
The final stage before MDMA-assisted psychotherapy in treating PTSD can become an FDA-approved treatment are Phase 3 trials. These trials already kicked off in September 2018, after delays in producing the MDMA. Between 200 and 300 subjects across 16 different sites in the US, Canada and Israel are participating, it should take two years to complete this stage, with ultimate FDA approval on track for sometime in 2021.
The new study was published in the Journal of Pharmacology.