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A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT02061293
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
Heffter Research Institute
University of New Mexico
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE February 7, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date April 29, 2019
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
percent heavy drinking days [ Time Frame: weeks 5-36 ]
Time-line Follow-back
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
percent heavy drinking days [ Time Frame: weeks 5-36 ]
The 32 weeks following the first drug administration session
Change History Complete list of historical versions of study NCT02061293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • Changes in vital signs [ Time Frame: 0-6 hours following drug administration at 4 weeks and 8 weeks ]
    Blood pressure and pulse will be measured at 30-60 minute intervals during first 6 hours of drug administration sessions.
  • adverse events [ Time Frame: weeks 0-54 ]
  • Percent days abstinent [ Time Frame: weeks 5-54 ]
  • drinks per drinking day [ Time Frame: weeks 5-54 ]
  • days to first drinking day [ Time Frame: weeks 5-54 ]
  • Days to first heavy drinking day [ Time Frame: weeks 5-54 ]
  • consequences of drinking [ Time Frame: weeks 5-54 ]
    Short inventory of problems
  • craving [ Time Frame: weeks 5-54 ]
    Penn Alcohol Craving Scale
  • self efficacy [ Time Frame: weeks 5-54 ]
    Alcohol Abstinence Self-efficacy Scale
  • Motivation to change drinking behavior [ Time Frame: weeks 5-54 ]
    Readiness rulers
  • percent heavy drinking days [ Time Frame: weeks 37-54 ]
    Time-line Follow-back
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • Changes in vital signs [ Time Frame: 0-6 hours following drug administration at 4 weeks and 8 weeks ]
    Blood pressure and pulse will be measured at 30-60 minute intervals during first 6 hours of drug administration sessions.
  • adverse events [ Time Frame: weeks 0-36 ]
  • Percent days abstinent [ Time Frame: weeks 5-36 ]
  • drinks per drinking day [ Time Frame: weeks 5-36 ]
  • days to first drinking day [ Time Frame: weeks 5-36 ]
  • Days to first heavy drinking day [ Time Frame: weeks 5-36 ]
  • consequences of drinking [ Time Frame: weeks 5-36 ]
    Short inventory of problems
  • craving [ Time Frame: weeks 5-36 ]
    Penn Alcohol Craving Scale
  • self efficacy [ Time Frame: weeks 5-36 ]
    Alcohol Abstinence Self-efficacy Scale
  • Motivation to change drinking behavior [ Time Frame: weeks 5-36 ]
    Readiness rulers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Official Title  ICMJE A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Brief Summary Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.
Detailed Description

Two to four sites will participate in this study. Aims of the study are 1) to characterize the acute effects of PO psilocybin 25 mg/70 kg, 30 mg/70 kg, and 40 mg/70 kg in alcohol dependent patients; 2) to evaluate the effect of psilocybin treatment on drinking outcomes for 32 weeks after the first administration, relative to diphenhydramine control; 3) to test whether or not characteristics of the drug administration session experiences mediate effects of psilocybin on short-term (1 week) persisting effects and post-session drinking behavior, 4) to evaluate the explanatory value of changes in alcohol craving, self-efficacy, motivation, and other psychological domains in accounting for the observed experimental effect of psilocybin relative to diphenhydramine control, and 5) to evaluate pre-post changes in drinking in participants after they receive psilocybin in the third session.

The total duration of psychosocial treatment in the double-blind period will be 12 weeks, and double-blind drug administration sessions will occur after 4 and 8 weeks. In the first psilocybin session, a dose of 25 mg/70 kg will be administered. Depending on the response in the first session, the dose for the second session may be increased to 30 mg/70 kg or 40 mg/70 kg, or held at 25mg/70kg. The dose of diphenhydramine will start at 50 mg, and may be increased to 100 mg or held at 50 mg in the second session, depending on response in the first session. Following completion of the double-blind period (34 weeks after randomization) all participants who meet interim safety criteria will be offered an additional session in which psilocybin will be administered. The drug will be administered during 8-hour sessions in an outpatient setting under close medical and psychiatric monitoring. The drug administration sessions will occur in the context of an extended version of Motivational Enhancement Therapy (Motivational Enhancement and Taking Action, META) with the addition of standardized preparation before and debriefing and follow-up after the psilocybin administration sessions. Extensive screening and baseline assessment will be completed, including thorough safety screening and assessment of participant characteristics that could potentially moderate treatment response. Within-session and short-term persisting effects will be assessed. 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 until 50 weeks after the first drug administration session, for a total of 54 weeks from the initiation of treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: Psilocybin
  • Drug: Diphenhydramine
  • Behavioral: Motivational Enhancement and Taking Action (META)
    Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
Study Arms  ICMJE
  • Experimental: Psilocybin
    Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8. Psilocybin 25-40 mg/70 kg administered at 38 weeks.
    Interventions:
    • Drug: Psilocybin
    • Behavioral: Motivational Enhancement and Taking Action (META)
  • Active Comparator: Diphenhydramine
    Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8. Psilocybin 25 mg/70 kg administered at 38 weeks.
    Interventions:
    • Drug: Diphenhydramine
    • Behavioral: Motivational Enhancement and Taking Action (META)
Publications * Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females age 25-65 with SCID (DSM-IV) diagnosis of alcohol dependence who
  2. Want to stop or decrease their drinking
  3. Are not participating in any formal treatment for alcohol dependence (12-step meetings are not considered treatment)
  4. Are able to provide voluntary informed consent
  5. Have at least 4 heavy drinking days in the past 30 days
  6. If female of childbearing potential, are willing to use approved form of contraception from screening until after the psilocybin administration sessions
  7. Have a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions
  8. Are able to provide adequate locator information.

Exclusion Criteria:

  1. Medical conditions that would preclude safe participation in the trial (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, heart failure, uncontrolled hypertension (above 165/95 mmHg at screening), history of cerebrovascular accident, asthma, hyperthyroidism, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction)
  2. Exclusionary psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, current post-traumatic stress disorder, current suicidality or history of medically serious suicide attempt)
  3. Cognitive impairment (Folstein Mini Mental State Exam score < 26)
  4. A family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives)
  5. History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses;
  6. Cocaine, psychostimulant, opioid, or cannabis dependence (past 12 months)
  7. Current non-medical use of cocaine, psychostimulants, or opioids (past 30 days)
  8. Significant alcohol withdrawal (CIWA-Ar score greater than 7. Patients presenting at screening in withdrawal may be referred for detoxification and reassessed within 30 days)
  9. Serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction)
  10. Serious abnormalities of complete blood count or chemistries
  11. Active legal problems with the potential to result in incarceration
  12. Pregnancy or lactation
  13. Need to take medication with significant potential to interact with study medications (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents, lithium, anticonvulsants).
  14. Allergy or hypersensitivity to psilocybin or diphenhydramine.
  15. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, 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: Lindsey Owens, MA 646-501-4199 Lindsey.Owens@nyumc.org
Contact: Samantha Podrebarac, MSc 212-263-0912 Samantha.Podrebarac@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061293
Other Study ID Numbers  ICMJE 14-00614
Heffter 113080-2 ( Other Grant/Funding Number: Heffter Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE
  • Heffter Research Institute
  • University of New Mexico
Investigators  ICMJE
Principal Investigator: Michael P Bogenschutz, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date April 2019

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