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Mdma Clinical Trials


A Phase 1/2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)


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

Id: NCT02876172

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: October 2016

Last Update: April 22, 2021

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted psychotherapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants.

Conditions:
  • Posttraumatic Stress Disorder


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