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Trial record 2 of 38 for:    Open Studies | "Cocaine-Related Disorders"

Psilocybin-facilitated Treatment for Cocaine Use

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Peter Hendricks, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02037126
First received: January 13, 2014
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Cocaine-Related Disorders
Drug: Psilocybin
Drug: Diphenhydramine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psilocybin-facilitated Treatment for Cocaine Use: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2015
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21 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:

  • 20 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037126

Contacts
Contact: Peter S. Hendricks, Ph.D. 415-509-7376 phendricks@uab.edu
Contact: Karen Cropsey, Psy.D. 205-514-2025 kcropsey@uab.edu

Locations
United States, Alabama
UAB Outpatient Clinical Research Unit Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Peter S Hendricks, Ph.D.    415-509-7376    phendricks@uab.edu   
Sponsors and Collaborators
Peter Hendricks
Investigators
Principal Investigator: Peter S. Hendricks, Ph.D. UAB School of Public Health Department of Health Behavior
  More Information

No publications provided

Responsible Party: Peter Hendricks, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02037126     History of Changes
Other Study ID Numbers: IND_121000
Study First Received: January 13, 2014
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Diphenhydramine
Promethazine
Psilocybine
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Antiemetics
Antipruritics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Hallucinogens
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014