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Mdma Clinical Trials


An Open-Label, Multi-Site Phase 2 Study of the Safety and Feasibility of MDMA-Assisted Psychotherapy for Eating Disorders


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

Id: NCT04454684

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Not yet recruiting

Start Date: November 2020

Last Update: November 17, 2020

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This Phase 2, open-label, multi-site study will explore the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy and adjunctive caregiver involvement in the treatment of 18 participants with eating disorders. The study will enroll 12 participants with anorexia nervosa restricting-type (AN-R) and six participants with binge eating disorder (BED). A supportive caregiver, such as a parent or partner, for each participant will also be recruited to participate in the study and receive non-drug psychotherapy support. The study will consist of Preparatory Sessions, Experimental Sessions of MDMA-assisted psychotherapy, as well as Individual and Dyadic Integrative Sessions.

A flexible dose of MDMA will be given during Experimental Sessions, ranging from 80 to 120 mg with a supplemental half-dose of 40 or 60 mg 1.5 to 2 hours later, respectively, unless contraindicated. The primary outcome measure is the change in Eating Disorder Examination (EDE) results from Baseline to Visit 16 (Study Termination).

Conditions:
  • Anorexia Nervosa Restricting Type
  • Binge-Eating Disorder


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