Buspirone Treatment for Marijuana Dependence

Study Overview
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Brief Summary
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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.

Official Title
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Buspirone Treatment for Marijuana Dependence

Conditions
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Marijuana Dependence

Intervention / Treatment
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* Drug: Buspirone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone<br>Buspirone | Drug: Buspirone<br>* Flexible dose, up to 60 mg daily<br>* Other names: Buspar;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Flexible dose, up to 60 mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in the Study | Number of days subjects remained active in the study | 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. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marijuana, Buspirone, Contingency management, Motivational enhancement therapy