Evidence map›Paper›PMID 35286849›Full record

Trial reportDrug and alcohol dependence2022

The effects of MDMA-assisted therapy on alcohol and substance use in a phase 3 trial for treatment of severe PTSD.

Christopher R Nicholas, Julie B Wang, Allison Coker, Jennifer M Mitchell, Sukhpreet S Klaire, Berra Yazar-Klosinski, Amy Emerson, Randy T Brown, Rick Doblin

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug and alcohol dependence, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
10.6field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  5. MDMA alters fear extinction, and reduces alcohol consumption in inbred alcohol preferring iP rats but not outbred Wistar rats.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026
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  19. Ayahuasca: A review of historical, pharmacological, and therapeutic aspects.PCN reports : psychiatry and clinical neurosciences · 2023
    Review
  20. Perceptions of psychedelic-assisted therapy among Black Americans.Journal of mood and anxiety disorders · 2023
    Article
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

9 authors at 5 institutions in 2 countries.

Christopher R NicholasUniversity of Wisconsin-Madison, Department of Family Medicine and Community Health, Madison, WI, USA. Electronic address: christopher.nicholas@fammed.wisc.edu.
Julie B WangMAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA.
Allison CokerMAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA; University of California, San Francisco, Department of Neurology, San Francisco, CA, USA.
Jennifer M MitchellUniversity of California, San Francisco, Department of Neurology, San Francisco, CA, USA; University of California, San Francisco, Department of Psychiatry and Behavioral Sciences, San Francisco, CA, USA.
Sukhpreet S KlaireBritish Columbia Centre on Substance Use, Vancouver, BC, Canada.
Berra Yazar-KlosinskiMultidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA.
Amy EmersonMAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA.
Randy T BrownUniversity of Wisconsin-Madison, Department of Family Medicine and Community Health, Madison, WI, USA.
Rick DoblinMultidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA.
Multidisciplinary Association for Psychedelic Studies · USPublic Service Electric and Gas (United States) · USUniversity of California, San Francisco · USUniversity of Wisconsin–Madison · USBritish Columbia Centre on Substance Use · CA

Funding

Mentoring the next generation of addiction clinician scientists while responding to the opioid epidemicR25DA037756 · NIDA · UNIVERSITY OF BRITISH COLUMBIA · PI FAIRBAIRN, NADIA · 2014 to 2023
$3.6M
NIDA NIH HHS R25 DA037756
6 · The paper itself

Abstract

backgroundPost-traumatic stress disorder (PTSD) is commonly associated with alcohol and substance use disorders (ASUD). A randomized, placebo-controlled, phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for the treatment of severe PTSD. This analysis explores patterns of alcohol and substance use in patients receiving MDMA-AT compared to placebo plus therapy (Placebo+Therapy).

methodsAdult participants with severe PTSD (n = 90) were randomized to three blinded trauma-focused therapy sessions with either MDMA-AT or Placebo+Therapy. Eligible participants met DSM-5 criteria for severe PTSD and could meet criteria for mild (current) or moderate (early remission) alcohol or cannabis use disorder; other SUDs were excluded. The current analyses examined outcomes on standardized measures of hazardous alcohol (i.e., Alcohol Use Disorder Identification Test; AUDIT) and drug (i.e., Drug Use Disorder Identification Test; DUDIT) use at baseline prior to randomization and at study termination.

resultsThere were no treatment group differences in AUDIT or DUDIT scores at baseline. Compared to Placebo+therapy, MDMA-AT was associated with a significantly greater reduction in mean (SD) AUDIT change scores (Δ = -1.02 (3.52) as compared to placebo (Δ = 0.40 (2.70), F (80, 1) = 4.20, p = 0.0436; Hedge's g= .45). Changes in DUDIT scores were not significantly different between treatment groups.

conclusionsMDMA-AT for severe PTSD may also lead to subclinical improvements in alcohol use. MDMA-AT does not appear to increase risk of illicit drug use. These data provide preliminary evidence to support the development of MDMA-AT as an integrated treatment for co-occurring PTSD and ASUD.

Indexed as

AlcoholismN-Methyl-3,4-methylenedioxyamphetamineStress Disorders, Post-TraumaticSubstance-Related DisordersAdultCombined Modality TherapyEthanolHumansTreatment OutcomeEthanolN-Methyl-3,4-methylenedioxyamphetamineAlcohol useMDMAPost-traumatic stress disorderSubstance use

Identifiers

PMID35286849
PMCPMC9750500
OpenAlexW4211151055

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.