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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061293
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : May 25, 2021
Heffter Research Institute
University of New Mexico
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Psilocybin Drug: Diphenhydramine Behavioral: Motivational Enhancement and Taking Action (META) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Study Start Date : June 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
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.
Drug: Psilocybin
Behavioral: Motivational Enhancement and Taking Action (META)
Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.

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.
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.

Primary Outcome Measures :
  1. percent heavy drinking days [ Time Frame: weeks 5-36 ]
    Time-line Follow-back

Secondary Outcome Measures :
  1. 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.

  2. adverse events [ Time Frame: weeks 0-54 ]
  3. Percent days abstinent [ Time Frame: weeks 5-54 ]
  4. drinks per drinking day [ Time Frame: weeks 5-54 ]
  5. days to first drinking day [ Time Frame: weeks 5-54 ]
  6. Days to first heavy drinking day [ Time Frame: weeks 5-54 ]
  7. consequences of drinking [ Time Frame: weeks 5-54 ]
    Short inventory of problems

  8. craving [ Time Frame: weeks 5-54 ]
    Penn Alcohol Craving Scale

  9. self efficacy [ Time Frame: weeks 5-54 ]
    Alcohol Abstinence Self-efficacy Scale

  10. Motivation to change drinking behavior [ Time Frame: weeks 5-54 ]
    Readiness rulers

  11. percent heavy drinking days [ Time Frame: weeks 37-54 ]
    Time-line Follow-back

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, QTc prolongation [QTc > .045 for men, QTc > .047 for women])
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061293

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United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Clinical and Translational Science Institute, NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Heffter Research Institute
University of New Mexico
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Principal Investigator: Michael P Bogenschutz, MD NYU Langone Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NYU Langone Health Identifier: NCT02061293    
Other Study ID Numbers: 14-00614
Heffter 113080-2 ( Other Grant/Funding Number: Heffter Research Institute )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Dermatologic Agents
Psychotropic Drugs