Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients with Alcohol Use Disorder
Open-label proof-of-concept feasibility study (n=20) assessing safety, tolerability, and acceptability of MDMA-assisted psychotherapy (oral MDMA capsules) in detoxified patients with alcohol use disorder.
Details
Proof-of-concept, therapist-supported MDMA-assisted psychotherapy delivered over an 8-week programme to detoxified patients with alcohol use disorder; primary outcomes are safety and tolerability and feasibility of delivering the intervention.
Intervention uses oral MDMA capsules (IMP strength documented as 62.5 mg). Secondary outcomes include drinking behaviour, psychosocial functioning and quality of life measured up to 9 months.
Sponsor: Imperial College London; competent authority decision authorised (MHRA) and favourable ethics opinion recorded in EudraCT.