Clinical TrialAlcohol Use Disorder (AUD)PsilocybinCompleted

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

Open-label pilot study (N = 10) of two supervised oral psilocybin sessions combined with a 12-session MET behavioural intervention for alcohol dependence, assessing feasibility, safety, and preliminary drinking outcomes.

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

Detailed Description

Open-label, single-group Phase II pilot administering two all-day oral psilocybin sessions (0.3 and 0.4 mg/kg, 4 weeks apart) alongside a 12-week manualised Motivational Enhancement Therapy programme including preparation and debriefing.

Outcomes include drinking behaviour and potential mediators (motivation, self-efficacy, craving), mood and anxiety measures, spiritual dimensions, safety and adverse events, with follow-up to 24 weeks post-treatment.

Study Protocol

Preparation

sessions

Dosing

2 sessions
480 min each

Integration

sessions

Therapeutic Protocol

mi

Study Arms & Interventions

Psilocybin

experimental

Two supervised oral psilocybin administration sessions combined with a 12-session manualised outpatient psychosocial intervention (MET) over 12 weeks.

Interventions

  • Psilocybin0.3 - 0.4 mg/kg
    via Oral• two sessions• 2 doses total

    Two doses (0.3 mg/kg and 0.4 mg/kg) given in separate all-day sessions 4 weeks apart; delivered with 12-session MET including preparation and debriefing.

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Males and females age 25-65 with diagnosis of alcohol dependence (DSM-IV);
  • 2. Concerned about their drinking, not planning to pursue other treatment (12-step meetings allowed);
  • 3. Able to provide voluntary informed consent;
  • 4. At least 2 heavy drinking days in the past 30 days;
  • 5. Willing to commit to abstinence from time of first psilocybin session until end of treatment;
  • 6. At least 24 hours abstinence from alcohol at time of psilocybin sessions;
  • 7. If female of childbearing potential, willing to use contraception from screening until after sessions;
  • 8. Having a family member or friend to pick them up and stay overnight after sessions;
  • 9. Able to provide adequate locator information.

Exclusion Criteria

  • 1. Exclusionary medical conditions (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, uncontrolled hypertension, history of cerebrovascular accident, severe obesity (BMI ≥35));
  • 2. Exclusionary psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder, current major depression, current PTSD, current suicidality);
  • 3. Family history of schizophrenia, schizoaffective disorder, bipolar disorder, or suicide (first or second degree relatives);
  • 4. Lifetime hallucinogen use on >10 occasions, or any use in past 30 days;
  • 5. Cocaine, psychostimulant, or opioid dependence (past 12 months) or current (past 30 days) use;
  • 6. History of medically significant suicide attempt or violent crime;
  • 7. Significant alcohol withdrawal (CIWA-Ar >7);
  • 8. Exclusionary laboratory abnormalities (LFT >5× normal, ECG evidence of ischemia, serious CBC/chemistry abnormalities);
  • 9. Active legal problems with potential for incarceration;
  • 10. Pregnancy or lactation;
  • 11. Need to take excluded medications (e.g., antidepressants, antipsychotics, psychostimulants, pharmacologic addiction treatments);
  • 12. High risk of adverse emotional reaction based on investigator evaluation (e.g., serious personality disorder, serious stressors, lack of social support).

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2012-01-01
    End: 2014-03-01
  • Compound
    Psilocybin
  • Topic
    Alcohol Use Disorder (AUD)

Locations

University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States

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