Evidence map›Paper›PMID 42409408›Full record

ArticleBMJ open2026

MDMA-assisted PTSD and Alcohol Therapy Trial (MPATHY): study protocol for a double-blind, randomised, controlled outpatient trial of MDMA-assisted integrated exposure-based therapy for comorbid post-traumatic stress disorder and alcohol use disorder.

Kirsten C Morley, S Arunogiri, K Mills, J Watt, M Teesson, A Baillie, Y Y Lee, A Morse, S E Back, D I Lubman and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05709353 (A Randomised, Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05709353 phase2unknown statusnot on this map

A Randomised, Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder

TypeinterventionalSponsorUniversity of SydneyRan2023 to 2026Enrolled120ConditionsPTSD, Alcohol Use Disorder, Alcohol Dependence, Post-traumatic Stress DisorderArmsProlonged exposure therapy, MDMA, Niacin
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kirsten C MorleySpecialty of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia kirsten.morley@sydney.edu.au.ORCID http://orcid.org/0000-0002-0868-9928
S ArunogiriEastern Health, Turning Point, Melbourne, Victoria, Australia.
K MillsThe Matilda Centre for Research in Mental Health and Substance Use, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-9714-1832
J WattSpecialty of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
M TeessonThe Matilda Centre for Research in Mental Health and Substance Use, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
A BaillieSchool of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Y Y LeeHealth Economics Group, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
A MorseNational Centre for Mental Health Research, Australian National University, Canberra, Australian Capital Territory, Australia.
S E BackDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
D I LubmanEastern Health, Turning Point, Melbourne, Victoria, Australia.
P S HaberSpecialty of Addiction Medicine, Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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. METHODS AND ANALYSIS: This world-first double-blind trial will aim to randomise 100 participants with PTSD+AUD to a regimen of Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) (12 sessions)+MDMA (80-160 mg: 2 dosing and 2 integration sessions) or COPE (12 sessions)+active control (niacin 250 mg: 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. ETHICS AND DISSEMINATION: 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 & 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. TRIAL REGISTRATION NUMBER: NCT05709353.

Indexed as

AlcoholismN-Methyl-3,4-methylenedioxyamphetamineStress Disorders, Post-TraumaticAdultCombined Modality TherapyComorbidityCost-Benefit AnalysisDouble-Blind MethodFemaleHumansRandomized Controlled Trials as TopicTreatment OutcomeN-Methyl-3,4-methylenedioxyamphetamineAnxiety disordersStress Disorders, Traumatic, AcuteSubstance misuse

Identifiers

PMID42409408
PMCPMC13343076

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.