Clinical TrialAlcohol Use Disorder (AUD)MDMAPlaceboUnknown status

Open-Label Proof of Concept Feasibility Study to Explore the Safety, Tolerability and Potential Role of MDMA-Assisted Psychotherapy for the Treatment of Detoxified Patients with Alcohol Use Disorder

Open-label proof-of-concept feasibility study (n=20) assessing safety, tolerability, and acceptability of MDMA-assisted psychotherapy (oral MDMA capsules) in detoxified patients with alcohol use disorder.

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Proof-of-concept, therapist-supported MDMA-assisted psychotherapy delivered over an 8-week programme to detoxified patients with alcohol use disorder; primary outcomes are safety and tolerability and feasibility of delivering the intervention.

Intervention uses oral MDMA capsules (IMP strength documented as 62.5 mg). Secondary outcomes include drinking behaviour, psychosocial functioning and quality of life measured up to 9 months.

Sponsor: Imperial College London; competent authority decision authorised (MHRA) and favourable ethics opinion recorded in EudraCT.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted psychotherapy

experimental

Oral MDMA capsules administered during drug-assisted psychotherapy sessions.

Interventions

  • MDMA62.5 mg
    via Oral• per dosing session

    Capsule strength 62.5 mg (IMP specification).

Placebo

inactive

Matching placebo capsule used as comparator per registry form.

Interventions

  • Placebo
    via Oral• per dosing session

    Placebo used (D.8 in EudraCT); details not specified in public record.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Informed consent
  • Primary diagnosis (DSM-5) of alcohol use disorder
  • Successful alcohol detoxification (no longer consuming any alcoholic substances)
  • Aged 18–65 years
  • Able to identify a supportive significant other who can accompany/provide supervision and be contacted for follow-up
  • Proficient in English
  • Agree to comply with protocol requirements

Exclusion Criteria

  • Lacking capacity
  • History of, or current, primary psychotic disorder, bipolar affective disorder type 1, or personality disorder
  • Present a serious suicide risk
  • Relevant abnormal clinical findings at screening judged by investigator to render subject unsuitable (including history of cardiac disease, hypertension, stroke; severe liver disease; epilepsy; malignant hyperthermia/Central Core Disease)
  • Regular user of ecstasy (>5 times in last 5 years or ≥2 times in prior 6 months)
  • Currently taking or unwilling/unable to stop medications inhibiting CYP2D6 or interacting meds listed in protocol (MAOIs, ritonavir, paroxetine, fluoxetine, citalopram, regular benzodiazepines, etc.) during 8-week therapy
  • Regular use/dependence on other drugs (benzodiazepines, synthetic cannabinoids, cocaine, heroin)
  • Females of childbearing potential must use effective contraception and not be breastfeeding during 8-week therapy
  • Participation in another investigational product study within last 3 months

Primary Results(4 publications)

Participants

N = 4B. et al. 2019 →
N = 14Mean age: 48 across armsB. et al. 2021 →
N = 14Mean age: 48 across armsB. et al. 2021 →
N = 14Mean age: 48 across armsH. et al. 2025 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
MDMA-assisted psychotherapyexperimental41(25.0%)—0(0.0%)0(0.0%)
Placeboinactive—————
MDMA-assisted psychotherapyexperimental140(0.0%)0(0.0%)0(0.0%)0(0.0%)
Placeboinactive—————
MDMA-assisted psychotherapyexperimental14——0(0.0%)—
Placeboinactive—————
MDMA-assisted psychotherapyexperimental14——0(0.0%)—
Placeboinactive—————

* One participant reported minor tinnitus and mild memory disturbance; authors noted these may be related to chronic postwithdrawal phenomena rather than MDMA. No serious adverse events related to MDMA were reported.

* This was an open-label study; no placebo arm data is provided in this case report.

* The study was open-label; results text states 'No unexpected adverse events were observed' and 'No patients experienced sustained abnormal physiological disturbance... or any other adverse events during MDMA sessions.' One participant had a transient abnormal rise in blood pressure but was asymptomatic and required no medical intervention.

* This was an open-label study; no placebo arm was used.

* The study was an open-label study. No serious adverse events or illicit MDMA use/cravings were reported. One participant had an abnormal increase in blood pressure due to forgetting antihypertensive medication, but all other physiological parameters remained within normal limits. 0% of patients reported illicit MDMA use or desire for it.

* No placebo arm was described in the provided text for this specific open-label study; the study was designed as a within-subjects, open-label safety and tolerability study.

* The paper states 'no unexpected adverse events were observed' and refers to a previous study (Sessa et al. 2021) for full safety and tolerability details. No specific counts for TEAEs are provided in this paper, only that no unexpected SAEs were reported.

* This was an open-label feasibility study; a placebo arm is not described in the provided text for this specific analysis.

Study Details

  • Status
    Unknown status
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2017-01-03
    End: 2025-12-30
  • Compounds
    MDMAPlacebo
  • Topic
    Alcohol Use Disorder (AUD)

Locations

United Kingdom

Related Publications

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

Published
Authors
Sessa, B., Sakal, C., O'Brien S., Nutt, D. J.

First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder

Published
Authors
Sessa, B., Higbed, L., Durant, C., Sakal, C., Titheradge, D., Williams, T. M., Rose-Morris, A., Brew-Girard, E., Burrows, S., Wiseman, C., Wilson, S., Rickard, J. A.

Debunking the myth of ‘Blue Mondays’: No evidence of affect drop after taking clinical MDMA

Published
Authors
Sessa, B., Aday, J. S., Curran, H. V., Measham, F., Higbed, L., Nutt, D. J., O'Biren, S.

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

Published
Authors
Thurgur, H., Sessa, B., Higbed, L., O'brien, S., Durant, C., Wilson, S., Szigeti, B., Morgan, C. J. A., Nutt, D. J.

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