Research library / Clinical trial
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
Mithoefer MC, Wagner MT, Mithoefer AT, et al. Journal of Psychopharmacology 2011;25(4):439-52
This small trial was the first completed randomised study of MDMA as an aid to psychotherapy. Twenty people with long-standing PTSD that had not improved with therapy or medication took part. Twelve received MDMA and eight received a placebo during two day-long therapy sessions, with ordinary therapy sessions before and after. PTSD symptoms improved significantly more in the MDMA group, and 10 of 12 MDMA patients met the study's response threshold compared with 2 of 8 on placebo. No serious drug-related harms were found, and memory and thinking tests did not worsen. With only 20 patients and a two-month comparison window, this study showed the approach was worth testing further rather than settling whether it works.
What it found
- PTSD scores (CAPS) fell significantly more with MDMA than placebo at all three post-baseline time points
- Clinical response: 10 of 12 (83%) on MDMA vs 2 of 8 (25%) on placebo
- No drug-related serious adverse events, no adverse neurocognitive effects and no clinically significant blood pressure rises