{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T01:36:12Z","timestamp":1794533772570,"version":"4.9.1"},"reference-count":79,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"unspecified","delay-in-days":5,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100025520","name":"MRFF","doi-asserted-by":"crossref","award":["APP 2014615"],"award-info":[{"award-number":["APP 2014615"]}],"id":[{"id":"10.13039\/501100025520","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,6,18]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The treatment of comorbid post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) is significantly more challenging than the treatment of either disorder alone. While gold standard evidence-based treatments exist for this comorbidity, clinically significant improvements are only observed in approximately half of clinical trial participants. The use of adjunctive pharmacotherapies, such as 3,4-methylenedioxymethamphetamine (MDMA), may serve to optimise gold standard interventions. The primary aim of the MDMA-assisted PTSD and Alcohol Therapy Trial study is to examine the therapeutic and cost-effectiveness of combining MDMA with evidence-based integrated care for comorbid PTSD+AUD. Specifically, we will examine MDMA-assisted integrated exposure therapy versus active control-assisted integrated exposure therapy in improving treatment outcomes for PTSD+AUD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This world-first double-blind trial will aim to randomise 100 participants with PTSD+AUD\u2009to a regimen of Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) (12 sessions)+MDMA (80\u2013160\u2009mg: 2 dosing and 2 integration sessions) or COPE (12 sessions)+active control (niacin 250\u2009mg: 2 dosing sessions and 2 integration sessions). All participants will receive medical management. The primary PTSD outcome will be the clinician-administered PTSD Scale for DSM-5. The primary drinking outcome will be the number of heavy drinking days (HDDs) per week, validated by phosphatidylethanol. Secondary PTSD and alcohol-related outcomes will include PTSD checklist for DSM-5 scores, absence of any HDDs and standard drinks per drinking day. We will also examine change in other clinical conditions and symptoms including depression, sleep disturbances and post-traumatic cognitions; treatment satisfaction and engagement; adverse events; and cost-effectiveness.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation-Good Clinical Practice guidelines. Ethical approval has been granted by the Sydney Local Health District Ethics Review Committee (X22-0121 &amp; 2022\/ETH00773). The results of this study will provide world-first data regarding safety, efficacy and cost-effectiveness of MDMA to optimise integrated exposure-based therapy for comorbid AUD and PTSD and will be disseminated to ensure wide accessibility and to support further research and clinical application.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05709353\">NCT05709353<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  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