A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
This Phase 2 pilot study was a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study consisted of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA. Only subjects who receive active dose MDMA will complete an optional third open-label experimental session.