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Mdma Clinical Trials

A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

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Id: NCT01689740

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: March 1, 2013

Last Update: July 6, 2022

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief 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.

  • Posttraumatic Stress Disorder (PTSD)

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