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Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT01534494
Recruitment Status : Unknown
Verified February 2014 by Michael Bogenschutz, University of New Mexico.
Recruitment status was:  Active, not recruiting
First Posted : February 16, 2012
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico

Tracking Information
First Submitted Date  ICMJE February 13, 2012
First Posted Date  ICMJE February 16, 2012
Last Update Posted Date February 10, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
change in percent heavy drinking days [ Time Frame: weeks 5-12 post initiation of treatment vs. 12 weeks prior to treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
Official Title  ICMJE Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: psilocybin
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534494
Other Study ID Numbers  ICMJE Heffter-UNM-HSC-15671
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Bogenschutz, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE Heffter Research Institute
Investigators  ICMJE
Principal Investigator: Michael P Bogenschutz, M.D. University of New Mexico
PRS Account University of New Mexico
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP