Clinical TrialAlcohol Use Disorder (AUD)MDMAUnknown status

Bristol Imperial MDMA in Alcoholism Study

Open-label, single-group feasibility study (n=20 planned; 2 MDMA-assisted psychotherapy sessions per participant) of MDMA-assisted psychotherapy in detoxified patients with Alcohol Use Disorder.

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

Detailed Description

Open-label, single-group feasibility study assessing safety and tolerability of MDMA-assisted psychotherapy in patients with alcohol use disorder after detoxification. Participants receive a 10-week psychotherapy course with two MDMA sessions (125 mg plus optional 62.5 mg booster, at sessions 3 and 7).

Outcomes include safety/tolerability, abstinence from alcohol, quality of life and psychosocial functioning; feasibility metrics and adverse events are monitored throughout follow-up.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted psychotherapy

experimental

All participants receive two sessions of MDMA-assisted psychotherapy within a 10-week psychotherapy course (MDMA sessions at session 3 and 7).

Interventions

  • MDMA125 mg
    via Oral• two sessions• 2 doses total

    Initial 125 mg with optional 62.5 mg booster 2 hours later; two session course (weeks 3 and 7).

  • Compound
    via Other

    Psychotherapy: 10-week course with MDMA sessions at sessions 3 and 7.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • Informed consent
  • Primary diagnosis (DSM-5) of alcohol use disorder
  • Successful alcohol detoxification (no longer consuming any alcoholic substances)
  • Between 18 and 65 years old
  • Able to identify in advance a supportive significant other who could accompany the patient to study visits or be contacted to assist with follow-up
  • Proficient in speaking and reading English
  • Agree to comply with requirements of protocol

Exclusion Criteria

  • Exclusion Criteria
  • Lacking capacity
  • History of, or a current, primary psychotic disorder, bipolar affective disorder type 1 or personality disorder
  • Present a serious suicide risk (see details)
  • Relevant abnormal clinical findings at screening judged by investigator to render subject unsuitable (including but not limited to history of cardiac disease, hypertension, stroke; severe liver disease; epilepsy; malignant hyperthermia)
  • Regular user of ecstasy (e.g., >5 times in last 5 years or ≥2 times in the 6 months prior to study)
  • Currently taking or unwilling/unable to stop medications inhibiting CYP2D6 or interacting drugs (including MAOIs, ritonavir, paroxetine, fluoxetine, citalopram, regular benzodiazepines) during the 8-week MDMA-assisted therapy
  • Regular use of or dependence on other drugs (benzodiazepines, synthetic cannabinoids, cocaine, heroin)
  • Females of childbearing potential must use effective contraception for at least six days after MDMA administration and must not be pregnant or breastfeeding during treatment phase
  • Males with partners of childbearing potential must confirm use of effective contraception for at least six days after MDMA administration and confirm partner will also
  • Participation in a study involving an investigational product in the last three months
  • Patients at additional risk from immunosuppression or with active infection or recent infections within 4 weeks of MDMA administration

Study Details

  • Status
    Unknown status
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2018-04-18
    End: 2020-06-12
  • Compound
    MDMA
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Study Center: University of Bristol — Bristol, United Kingdom

Related Publications

Paywallindividual

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

This open-label study (n=14) study assessed the decline in mood and cognition, also known as 'Blue Mondays,' that are believed to occur following MDMA use. The study assessed these side effects in participants being treated with MDMA (125mg followed by a 62.5mg dose 2hrs later) for alcohol use disorder (AUD). It was found participants maintained a positive mood during the week following the dosing session and suggests that the 'come downs' associated with MDMA may be associated with illicit sourcing of the substance and recreational use.

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

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