Trial PaperObsessive-Compulsive Disorder (OCD)PTSDAlcohol Use Disorder (AUD)Safety & Risk ManagementInterpersonal Functioning & Social ConnectednessSubstance Use Disorders (SUD)MDMA

MDMA-assisted psychotherapy for AUD: Bayesian analysis of WHO drinking risk level and exploratory analysis of drinking behavior and psychosocial functioning at 3 months follow-up

In an open‑label feasibility study of 14 recently detoxified participants, Bayesian analysis estimated a 55–63% probability that MDMA‑assisted psychotherapy produced a two‑level reduction in WHO drinking‑risk at 3‑month follow‑up, with preliminary reductions in alcohol craving and improvements in sleep and psychosocial functioning. The paper frames a harm‑reduction endpoint for AUD and provides early evidence that MDMA‑assisted psychotherapy may improve quality of life alongside reduced drinking.

Authors

  • David Nutt
  • Ben Sessa
  • Balázs Szigeti

Published

Alcohol and Alcoholism
individual Study

Abstract

Aims

Safety and tolerability data from the first open-label feasibility study of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for alcohol use disorder was recently published. This paper presents a Bayesian analysis of the impact of MDMA-assisted psychotherapy on treatment success, defined as 2-level reduction in the World Health Organization (WHO) drinking risk at the 3 months follow-up. We also examined the impact on drinking behavior and psychosocial measures at 3 months compared to baseline.

Methods

Fourteen participants with a diagnosis of alcohol use disorder who had recently undergone detoxification completed an eight-week course of ten psychotherapy sessions, including two sessions with MDMA. Measures assessing drinking behavior, quality of life, sleep, self-compassion, and empathy were collected. Bayesian analysis using flat and skeptical priors was performed to determine treatment success defined as a 2-level reduction in WHO drinking risk.

Results

Bayesian analysis suggested that the probability of a 2-level reduction in WHO drinking risk from baseline to 3 months post-treatment is 55%–63%, based upon either a flat or skeptical prior respectively. We present preliminary findings suggesting reductions in alcohol craving (measured by the Penn Alcohol Craving Scale and Obsessive Compulsive Drinking Scale) and improvements in sleep and aspects of psychosocial functioning at 3 months follow-up compared to baseline.

Conclusions

The Bayesian analysis provides a useful harm reduction endpoint interpretation of drinking in terms of a 2-level reduction in WHO drinking risk. Further findings provide preliminary insights into the potential impact of MDMA-assisted psychotherapy on quality of life and well-being in addition to reductions in drinking. ClinicalTrials.gov ID: NCT04158778.

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Research Summary of 'MDMA-assisted psychotherapy for AUD: Bayesian analysis of WHO drinking risk level and exploratory analysis of drinking behavior and psychosocial functioning at 3 months follow-up'

Introduction

Thurgur and colleagues situate this work within the recent resurgence of clinical research on MDMA-assisted psychotherapy, noting robust Phase III evidence for PTSD and interest in applying the approach to other disorders linked with trauma, including alcohol use disorder (AUD). Earlier open-label work by the study team established safety and tolerability for MDMA-assisted psychotherapy in AUD and reported reductions in drinking and improvements in mood up to 9 months, but questions remain about clinically meaningful drinking endpoints, broader psychosocial outcomes, and potential mediators such as craving. This paper re-analyses data from that initial feasibility trial to address two aims. First, the investigators apply a Bayesian framework to estimate the probability that participants achieved a clinically relevant harm-reduction endpoint—defined as a 2-level reduction in World Health Organization (WHO) drinking risk—at 3 months post-treatment. Second, the study reports exploratory analyses of drinking behaviour, craving, quality of life (QOL), sleep, self-compassion and empathy at 3 months versus baseline to provide preliminary evidence on broader wellbeing outcomes beyond alcohol consumption metrics.

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Study Details

References (12)

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