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.
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.
Oral MDMA capsules administered during drug-assisted psychotherapy sessions.
Capsule strength 62.5 mg (IMP specification).
Matching placebo capsule used as comparator per registry form.
Placebo used (D.8 in EudraCT); details not specified in public record.
In the first open‑label study of MDMA‑assisted psychotherapy for alcohol use disorder (BIMA), 14 post‑detox participants tolerated two 187.5 mg MDMA sessions with no unexpected adverse events and showed improved psychosocial functioning. At nine months average alcohol use fell from 130.6 to 18.7 units per week, supporting safety and signalling therapeutic potential that now warrants controlled trials.