Phase 4
N=175
Buspirone Treatment for Marijuana Dependence
Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00875836 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Percent Marijuana-negative Urine Drug Screens (UDS) — 7.2; 6.4 percentage of UDS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Buspirone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Marijuana-negative Urine Drug Screens (UDS) |
7.2; 6.4 | — |
| SECONDARY Retention in the Study |
79; 84 | — |
| SECONDARY Marijuana Craving |
29.6; 28.4 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00875836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.