Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

NCT01534494 | Completed Phase 2 Results DMC

• 1 other identifier: Heffter-UNM-HSC-15671
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; psilocybin; clinical trial; motivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

• Change in Percent Heavy Drinking Days

  weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Study Arms (1)

psilocybin

EXPERIMENTAL

Drug: Psilocybin

Interventions

Psilocybin DRUG

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.

psilocybin

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Concerned about their drinking, but not planning to pursue any other form of treatment at present (12-step meetings are not considered treatment);
• Able to provide voluntary informed consent;
• Having at least 2 heavy drinking days in the past 30 days;
• Willing to commit to the goal of abstinence at least from the time of the first psilocybin administration session until the end of treatment.
• At least 24 hours abstinence from alcohol at the time of the psilocybin administration sessions;
• If female of childbearing potential, willing to use approved form of contraception from screening until after the psilocybin administration sessions;
• Having a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions; and
• Able to provide adequate locator information.

You may not qualify if:

• A family history of schizophrenia, schizoaffective disorder, bipolar disorder, or suicide (first or second degree relatives);
• Lifetime history of hallucinogen use on more than 10 occasions, or any use in the past 30 days;
• Cocaine, psychostimulant, or opioid dependence (past 12 months) or current (past 30 days) use;
• A history of medically significant suicide attempt or violent crime;
• Significant alcohol withdrawal (CIWA-Ar score greater than 7);
• Active legal problems with the potential to result in incarceration;
• Pregnancy or lactation;
• The need to take excluded medication (e.g., antidepressants, antipsychotics, psychostimulants, pharmacologic treatments for addictions).
• 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).

Sponsors & Collaborators

• University of New Mexico: lead
• Heffter Research Institute: collaborator

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Limitations and Caveats

Open-label single-group study

Results Point of Contact

• Title: Michael Bogenschutz
• Organization: New York University Grossman School of Medicine

Michael.Bogenschutz@nyulangone.org

5059999325

Study Officials

• Michael P Bogenschutz, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2023-09

Locations

US (1)