Clinical TrialAlcohol Use Disorder (AUD)KetaminePlaceboNot yet recruiting

Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder

Randomised, parallel-group Phase II trial (n=80) comparing oral ketamine (1.5 mg/kg) versus active control midazolam (0.05 mg/kg) given in weeks 3 and 5 within a 6‑week group mindfulness programme for moderate–severe Alcohol Use Disorder.

Target Enrollment
80 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Participants receive a manualised in‑person group mindfulness programme once weekly for six weeks (groups ≤10, delivered by two trained facilitators). Randomised arms receive oral ketamine or active control midazolam during the mindfulness sessions in weeks 3 and 5.

Primary outcome is self‑reported drinking days by timeline follow‑back to week 10; secondary measures include alcohol craving VAS, breathalyser at each session, blood tests for longer‑term alcohol use, and follow‑up phone calls at 3 and 6 months.

Study Protocol

Preparation

sessions

Dosing

2 sessions
180 min each

Integration

sessions

Therapeutic Protocol

mindfulness

Study Arms & Interventions

Ketamine

experimental

Oral ketamine administered within manualised group mindfulness sessions (weeks 3 and 5).

Interventions

  • Ketamine1.5 mg/kg
    via Oral• single dose• 2 doses total

    Oral solution in juice given during weeks 3 and 5 of the 6‑week mindfulness programme.

Midazolam

active comparator

Oral midazolam as active control administered within mindfulness sessions (weeks 3 and 5).

Interventions

  • Placebo0.05 mg/kg
    via Oral• single dose• 2 doses total

    0.05 mg/kg in 50 mL orange juice given during weeks 3 and 5 (active control; compound recorded as placebo reference).

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Capable of understanding and signing an informed consent
  • Aged 18 years and over, and under 70 years old on the day of consent
  • Have an established diagnosis of moderate to severe AUD

Exclusion Criteria

  • Female participants who are or intend to become pregnant or are lactating.
  • Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them.
  • Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
  • Participants who are starting new antidepressants, anxiolytics or psychotherapy within four weeks of enrolment. Use of antidepressants, anxiolytics at stable doses > four weeks prior or psychotherapy is acceptable.
  • Active suicidal ideation as operationalise by a CSSR score of four or higher.
  • Participants with comorbid schizophrenia or bipolar disorder. Depression and anxiety is acceptable.
  • Participants with current other moderate to severe substance use disorder other than nicotine or caffeine.
  • Participants with severe personality disorders as judged elevated risk by the investigator.
  • Participants who are on parole.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2022-03-01
    End: 2023-12-31
  • Compounds
    KetaminePlacebo
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Unknown facility — Australia

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