Buspirone Treatment for Marijuana Dependence

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Buspirone	Buspirone	Buspirone

Primary Outcome Measures

Name	Time	Method
Percent Marijuana-negative Urine Drug Screens (UDS)	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 Outcome Measures

Name	Time	Method
Retention in the Study	participants were followed for twelve weeks	Number of days subjects remained active in the study
Marijuana Craving	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.