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Psilocybin-facilitated Treatment for Cocaine Use

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02037126
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : November 23, 2020
Information provided by (Responsible Party):
Peter Hendricks, University of Alabama at Birmingham

Brief Summary:

The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement (e.g., criminal involvement).

MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Psilocybin Drug: Diphenhydramine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study
Study Start Date : May 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Psilocybin administration
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
Drug: Psilocybin
this has been used in treating obsessive-compulsive disorders, cluster headaches, anxiety, and drug dependence.
Other Name: psychedelic compound

Active Comparator: Diphenhydramine administration
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
Drug: Diphenhydramine
This drug will be used as the control. Diphenhydramine is a histamine blocker.
Other Name: Benadryl

Primary Outcome Measures :
  1. The difference between the treatment and placebo groups in the number of participants with biochemically verified cocaine abstinence. [ Time Frame: 16 and 28 weeks after psilocybin or placebo administration. ]
    Number of subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) with biochemically verified cocaine presence as assessed via a urine drug screen.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 25 years of age and older
  • Score of at least 3 on the Severity of Dependence Scale
  • Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence questionnaire
  • Ability to read/write in English
  • No prior hallucinogen use or it will have been at least 3 years since their last use of a hallucinogen
  • Availability of 3 community observers to complete community observer forms via telephone around baseline and follow-up assessments.
  • Availability of a friend or family member into whose care the participant can be released following their drug administration session.
  • In good general health as assessed by detailed medical history and physical examination
  • Abstinence from cocaine for at least 7 days prior to experimental drug administration as confirmed via urinalysis and no signs of intoxication on other drugs.

Exclusion Criteria:

  • 24 years of age and younger
  • Women who are pregnant or breast feeding
  • Current psychiatric diagnoses other than substance abuse/dependence
  • Current hypertension (exceeding 140 systolic and 90 diastolic at resting as described below)
  • Use of tricyclic antidepressants, lithium, Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors, haloperidol, St. John's Wort, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity
  • History of any psychotic disorders
  • History of bipolar I or II disorder
  • First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders
  • Current suicidal or homicidal ideation
  • Planning to move from the Birmingham area in the next 6 months
  • Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)

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): NCT02037126

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Contact: Peter S. Hendricks, Ph.D. 205-202-1387
Contact: Sarah Simpson, B.S. 205-975-7721

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United States, Alabama
UAB Outpatient Clinical Research Unit Recruiting
Birmingham, Alabama, United States, 35294
Contact: Peter S Hendricks, Ph.D.    415-509-7376   
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Peter S. Hendricks, Ph.D. UAB School of Public Health Department of Health Behavior
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Responsible Party: Peter Hendricks, Associate Professor, University of Alabama at Birmingham Identifier: NCT02037126    
Other Study ID Numbers: IND_121000
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Cocaine-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