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

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

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