Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
This Phase 2 pilot study assessed the safety and efficacy of MDMA-assisted psychotherapy in
10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing
the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects
were enrolled in the open label full dose lead-in with 125 mg of MDMA, followed 1.5 to 2.5
hours later by a supplemental half-dose of 62.5 mg of MDMA. The remaining eight subjects
enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25
mg MDMA, with a supplemental dose of 12.5 mg MDMA) or a fully active dose of MDMA (125 mg,
with a supplemental dose of 62.5 mg MDMA) during two experimental psychotherapy session, each
lasting six to eight hours and scheduled three to five weeks apart. The extent of PTSD
symptoms was assessed at baseline and two months after the second experimental session using
the Clinician Administered PTSD Scale (CAPS) [Blake et al., 1995]. Subjects who enrolled in
Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study
and complete open-label experimental sessions with the fully active dose of MDMA on the same
schedule as Stage 1.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies