A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 24 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)
This pilot Phase 2 randomized, triple-blind study examined the safety and efficacy of MDMA-assisted therapy in 24 veterans, firefighters, and police officers with service-related PTSD. All participants received weekly non-drug therapy and three Experimental Sessions of MDMA-assisted therapy, scheduled three to five weeks apart. This study compared three different doses of MDMA to determine if they would successfully blind subjects, therapists, and the independent rater to dose received. 12 subjects received a full 125 mg dose of MDMA, followed by a 62.5 mg supplemental dose; seven subjects received an active dose of 75 mg of MDMA, followed by a supplemental 37.5 mg dose; and seven subjects received an active placebo dose of 30 mg of MDMA, followed by a supplemental 15 mg dose. Participants in the 30 mg and 75 mg groups subsequently underwent three 100-125 mg MDMA-assisted psychotherapy sessions in an open-label crossover, and all participants were assessed 12 months after the last MDMA session.
At the primary endpoint, the 75 mg and 125 mg groups had significantly greater decreases in PTSD symptom severity (p=0.001) than the 30 mg group. In the open-label crossover with full-dose MDMA, PTSD symptom severity significantly decreased in the group that had previously received 30 mg (p=0.01). PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (p<0.0001).
- Current Status: Completed
- ClinicalTrials.gov Record
- Study Protocol