Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

September 6, 2023 updated by: Michael Bogenschutz, University of New Mexico
This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in recent studies. Psilocybin administration will occur in the context of a behavioral intervention including a total of 12 sessions over 12 weeks, incorporating Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before and debriefing after the psilocybin administration sessions. The MET will incorporate attention to spirituality as well as drinking behavior as a primary subject of change. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured during treatment and for 24 weeks after the end of treatment. The investigators hypothesize that drinking will decrease following the psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks vs. baseline) will be observed among study participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females age 25-65 with diagnosis of alcohol dependence, as ascertained using the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV version);
  2. Concerned about their drinking, but not planning to pursue any other form of treatment at present (12-step meetings are not considered treatment);
  3. Able to provide voluntary informed consent;
  4. Having at least 2 heavy drinking days in the past 30 days;
  5. Willing to commit to the goal of abstinence at least from the time of the first psilocybin administration session until the end of treatment.
  6. At least 24 hours abstinence from alcohol at the time of the psilocybin administration sessions;
  7. If female of childbearing potential, willing to use approved form of contraception from screening until after the psilocybin administration sessions;
  8. Having a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions; and
  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 greater than or equal to 35);
  2. Exclusionary psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder, current major depression, current post-traumatic stress disorder, current suicidality);
  3. A family history of schizophrenia, schizoaffective disorder, bipolar disorder, or suicide (first or second degree relatives);
  4. Lifetime history of hallucinogen use on more than 10 occasions, or any use in the past 30 days;
  5. Cocaine, psychostimulant, or opioid dependence (past 12 months) or current (past 30 days) use;
  6. A history of medically significant suicide attempt or violent crime;
  7. Significant alcohol withdrawal (CIWA-Ar score greater than 7);
  8. Exclusionary laboratory abnormalities (any liver function test (LFT) greater than 5 times normal, ECG evidence of ischemia, serious abnormalities of complete blood count or chemistries);
  9. Active legal problems with the potential to result in incarceration;
  10. Pregnancy or lactation;
  11. The need to take excluded medication (e.g., antidepressants, antipsychotics, psychostimulants, pharmacologic treatments for addictions).
  12. High risk of adverse emotional reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of meaningful social support).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: psilocybin
Drug: Psilocybin
two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Percent Heavy Drinking Days
Time Frame: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment
weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

Heffter Research Institute

Investigators

  • Principal Investigator: Michael P Bogenschutz, M.D., University of New Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimated)

February 16, 2012

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heffter-UNM-HSC-15671

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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