Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)
Status:
Completed
Trial end date:
2019-06-04
Target enrollment:
Participant gender:
Summary
This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed
with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been
identified and trained to work on the sponsor's planned Phase 3 studies will treat at least
one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed
by a supplemental half-dose, unless contraindicated, is administered during the Treatment
Period with manualized therapy in three open-label monthly Experimental Sessions. This
~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment
Period, each Experimental Session is followed by three Integrative Sessions of non-drug
psychotherapy. The primary outcome measure is the change in the Clinician Administered PTSD
Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary
outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS)
for PTSD for the MAPS studies total scores from Baseline to Visit 19.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies