{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T18:32:45Z","timestamp":1772908365492,"version":"3.50.1"},"reference-count":16,"publisher":"BMJ","issue":"7","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Case Rep"],"accepted":{"date-parts":[[2019,6,28]]},"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:p>We present the preliminary data in an ongoing open-label safety and tolerability proof of concept study exploring the potential role for 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in treating patients with alcohol use disorder. At this stage, seven participants have completed the full 8-week MDMA-assisted psychotherapy course, including two therapy sessions each with MDMA. This paper focuses on the safety and tolerability of the therapeutic course for the first four participants to complete treatment. Longer-term outcomes of drinking behaviour will be presented later when the full project data are published. Results show all four participants have successfully tolerated the treatment. There have been no serious adverse events related to MDMA, no unexpected physiological responses to the MDMA sessions or changes to blood results or electrocardiograms, measured before and after the 8-week course. We conclude that the treatment is well- tolerated and are making plans to expand the project into a randomised placebo-controlled study.<\/jats:p>","DOI":"10.1136\/bcr-2019-230109","type":"journal-article","created":{"date-parts":[[2019,7,15]],"date-time":"2019-07-15T08:25:30Z","timestamp":1563179130000},"page":"e230109","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["First study of safety and tolerability of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in patients with alcohol use disorder: preliminary data on the first four participants"],"prefix":"10.1136","volume":"12","author":[{"given":"Ben","family":"Sessa","sequence":"first","affiliation":[{"name":"Neuropsychopharmacology, Department of Medicine, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chloe","family":"Sakal","sequence":"additional","affiliation":[{"name":"Department of Medicine, Avon and Wiltshire Mental Health Partnership NHS Trust, Bath, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steve","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"Neuropsychopharmacology, Department of Medicine, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Nutt","sequence":"additional","affiliation":[{"name":"Neuropsychopharmacology, Department of Medicine, Imperial College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,7,15]]},"reference":[{"key":"2025082711530644000_12.7.e230109.1","doi-asserted-by":"crossref","first-page":"54","DOI":"10.2174\/18744737112059990005","article-title":"Can MDMA play a role in the treatment of substance abuse?","volume":"6","author":"Jerome","year":"2013","journal-title":"Curr Drug Abuse Rev"},{"key":"2025082711530644000_12.7.e230109.2","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.114.148031"},{"key":"2025082711530644000_12.7.e230109.3","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.neuropharm.2017.11.004","article-title":"Why MDMA therapy for alcohol use disorder? And why now?","volume":"142","author":"Sessa","year":"2018","journal-title":"Neuropharmacology"},{"key":"2025082711530644000_12.7.e230109.4","unstructured":"NICE. Alcohol-use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence. NICE clinical guideline 115. 2011 www.nice.org.uk\/CG115"},{"key":"2025082711530644000_12.7.e230109.5","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.120.1.83"},{"key":"2025082711530644000_12.7.e230109.6","unstructured":"HM Government. The Government\u2019s Alcohol Strategy: Secretary of State for the Home Department HM Government, 2012."},{"key":"2025082711530644000_12.7.e230109.7","unstructured":"Office for National Statistics. Alcohol-specific deaths in the UK: registered in 2017. https:\/\/www.ons.gov.uk\/peoplepopulationandcommunity\/healthandsocialcare\/causesofdeath\/bulletins\/alcoholrelateddeathsintheunitedkingdom\/registeredin2017 (Accessed 26th Feb 2019)."},{"key":"2025082711530644000_12.7.e230109.8","first-page":"92","article-title":"Factors related with relapse in male alcohol dependents: 12 months follow-up study","volume":"23","author":"Evren","year":"2010","journal-title":"J Psychiatry Neurol Sci"},{"key":"2025082711530644000_12.7.e230109.9","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2006.01310.x"},{"key":"2025082711530644000_12.7.e230109.10","unstructured":"First MB , Williams JBW , Karg RS , et al . Structured clinical interview for DSM-5\u2014research version (SCID-5 for DSM-5, Research Version; SCID-5-RV). Arlington, VA: American Psychiatric Association, 2015."},{"key":"2025082711530644000_12.7.e230109.11","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-7061(99)00238-1"},{"key":"2025082711530644000_12.7.e230109.12","doi-asserted-by":"publisher","DOI":"10.1080\/02791072.1986.10472364"},{"key":"2025082711530644000_12.7.e230109.13","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1002\/pnp.216","article-title":"Could MDMA be useful in the treatment of PTSD?","volume":"15","author":"Sessa","year":"2012","journal-title":"Progress in Neurol & Psychiatry"},{"key":"2025082711530644000_12.7.e230109.14","doi-asserted-by":"publisher","DOI":"10.1177\/0269881110378371"},{"key":"2025082711530644000_12.7.e230109.15","doi-asserted-by":"publisher","DOI":"10.1177\/0269881112456611"},{"key":"2025082711530644000_12.7.e230109.16","doi-asserted-by":"publisher","DOI":"10.1177\/0269881112464827"}],"container-title":["BMJ Case Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bcr-2019-230109","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,27]],"date-time":"2025-08-27T18:53:13Z","timestamp":1756320793000},"score":1,"resource":{"primary":{"URL":"https:\/\/casereports.bmj.com\/lookup\/doi\/10.1136\/bcr-2019-230109"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7]]},"references-count":16,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2019,7,15]]},"published-print":{"date-parts":[[2019,7]]}},"alternative-id":["10.1136\/bcr-2019-230109"],"URL":"https:\/\/doi.org\/10.1136\/bcr-2019-230109","relation":{},"ISSN":["1757-790X"],"issn-type":[{"value":"1757-790X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7]]}}}