Buspirone Treatment for Marijuana Dependence

Medical University of South Carolina175 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

175

Conditions

Marijuana Dependence

Interventions

BuspironeDRUG

Flexible dose, up to 60 mg daily

PlaceboDRUG

Flexible dose, up to 60 mg daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Percent Marijuana-negative Urine Drug Screens (UDS)

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Time frame: Participants provided a once-weekly urine sample for twelve weeks

Secondary Outcomes

Retention in the Study

Number of days subjects remained active in the study

Time frame: participants were followed for twelve weeks

Marijuana Craving

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.

Time frame: 8 Weeks

Data from ClinicalTrials.gov

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