A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders
Status:
Not yet recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies