This trial is active, not recruiting.

Condition marijuana dependence
Treatments buspirone, placebo
Phase phase 4
Sponsor Medical University of South Carolina
Collaborator National Institute on Drug Abuse (NIDA)
Start date September 2009
End date June 2014
Trial size 176 participants
Trial identifier NCT00875836, DPMCDA, R01DA026782


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
buspirone Buspar
30 mg capsules twice daily
(Placebo Comparator)
30 mg capsules twice daily

Primary Outcomes

Percent marijuana-positive urine drug screens
time frame: Weekly

Secondary Outcomes

Time to first negative urine screen
time frame: Weekly
Retention in the study
time frame: Weekly
Marijuana craving and withdrawal
time frame: Weekly

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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).

Additional Information

Official title Buspirone Treatment for Marijuana Dependence
Principal investigator Aimee McRae-Clark, Pharm.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.