Clinical TrialSingle-armAlcohol 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.

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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 Protocol, Arms & Participants

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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)

Study Team

Sponsors & Collaborators

Locations

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

Related Publications

Open AccessindividualPrimary

Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study

In a single-group proof-of-concept study of 10 participants with DSM‑IV alcohol dependence, psilocybin administered alongside motivational enhancement therapy produced a significant increase in abstinence after dosing that was largely maintained to 36 weeks, with the intensity of the first session strongly predicting subsequent reductions in drinking, craving and increased abstinence self‑efficacy. There were no significant treatment‑related adverse events, supporting the need for larger controlled trials to evaluate efficacy and mechanisms.

Published
Journal
Journal of Psychopharmacology
Authors
Bogenschutz, M. P., Forcehimes, A. A., Pommy, J. A., Wilcox, C. E., Barbosa, P., Strassman, R. J.
Open AccessindividualSecondary analysis

The psychedelic debriefing in alcohol dependence treatment: illustrating key change phenomena through qualitative content analysis of clinical sessions

This open-label pilot study (n=10) of psilocybin-assisted treatment of alcohol dependence (21mg/70kg) presents a qualitative content analysis of the 17 debriefing sessions conducted in the pilot study, which occurred the day after corresponding psilocybin medication sessions. Participants articulated a series of key phenomena related to change in drinking outcomes and acute subjective effects of psilocybin.

Published
Journal
Frontiers in Pharmacology
Authors
Kraehenmann, R., Nielson, E. M., May, D. G., Forcehimes, A. A., Bogenschutz, M. P.

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