MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
This Phase 2 pilot study is 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 will consist 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.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies