Buspirone Treatment for Marijuana Dependence

Overview

Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2014

Interventions

  • Drug: Buspirone
    • Flexible dose, up to 60 mg daily
  • Drug: Placebo
    • Flexible dose, up to 60 mg daily

Arms, Groups and Cohorts

  • Experimental: Buspirone
    • Buspirone
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Percent Marijuana-negative Urine Drug Screens (UDS)
    • Time Frame: Participants provided a once-weekly urine sample for twelve weeks
    • Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Secondary Measures

  • Retention in the Study
    • Time Frame: participants were followed for twelve weeks
    • Number of days subjects remained active in the study
  • Marijuana Craving
    • Time Frame: 8 Weeks
    • The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.

Participating in This Clinical Trial

Inclusion Criteria

  • Must meet DSM-IV criteria for marijuana dependence.
  • Must be between the ages of 18 and 65 years.
  • If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
  • Must consent to random assignment, and be willing to commit to psychosocial behavioral and medication treatment.
  • Must be able to read and provide informed consent.

Exclusion Criteria

  • Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
  • Must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder.
  • Must not pose a current suicidal or homicidal risk.
  • Must not meet current criteria for major depression.
  • Must not have evidence or history of serious hematologic, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurologic disease.
  • Must not require concomitant therapy with psychotropic medication.
  • Must not be currently dependent on other substances, with the exception of nicotine or caffeine.
  • Hypersensitivity to buspirone or any other product component.
  • Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aimee McRae-Clark, Professor – Medical University of South Carolina
  • Overall Official(s)
    • Aimee McRae-Clark, Pharm.D., Principal Investigator, Medical University of South Carolina

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