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Mdma Clinical Trials


An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (Canada)


To see complete record on clinicaltrials.gov, please visit this link

Id: NCT03485287

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: April 10, 2018

Last Update: July 1, 2021

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief 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 Sheehan Disability Scale (adapted SDS) total scores from Baseline to Visit 19.

Conditions:
  • Posttraumatic Stress Disorder


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