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Mdma Clinical Trials

A Randomized, Double-Blind, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

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Id: NCT01793610

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: October 2012

Last Update: July 11, 2022

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This Phase 2 pilot study examined the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant posttraumatic stress disorder (PTSD). This study is part of a global series of Phase 2 pilot clinical trials. This randomized, double-blind, dose response study assessed two active doses of MDMA, 100 mg and 125 mg, to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart. Subjects were prepared for MDMA-assisted psychotherapy prior to the first session in three preparatory sessions, and worked with the same pair of therapists throughout the study. After each MDMA-assisted psychotherapy session, subjects had three integrative sessions with their therapist team to process and understand their experience.

This study assessed the change in symptoms of PTSD, as measured by the Clinical Administered PTSD Scale (CAPS) [Blake et al., 1995], as well as symptoms of depression, as measured by the Beck Depression Inventory II (BDI-II) [Beck, A.T. and R.A, 1984; Beck, A.T., et al., 1996] from baseline enrollment to one month after the second MDMA-assisted psychotherapy session (primary endpoint).

Participants who received the comparator dose of MDMA (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions with an active dose of MDMA. People who received either of the active doses of MDMA in Stage 1 had a third MDMA-assisted psychotherapy session with another active dose of MDMA.

  • Posttraumatic Stress Disorder

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