Overview

This trial is active, not recruiting.

Condition alcohol dependence
Treatment psilocybin
Phase phase 2
Sponsor University of New Mexico
Collaborator Heffter Research Institute
Start date January 2012
End date September 2013
Trial size 10 participants
Trial identifier NCT01534494, Heffter-UNM-HSC-15671

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
change in percent heavy drinking days
time frame: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment

Eligibility Criteria

Male or female participants from 25 years up to 65 years old.

Inclusion Criteria: 1. Males and females age 25-65 with SCID diagnosis of alcohol dependence; 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).

Additional Information

Official title Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
Principal investigator Michael P Bogenschutz, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of New Mexico.