Clinical trial NCT00875836: Buspirone Treatment for Marijuana Dependence
Official title: Buspirone Treatment for Marijuana Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Marijuana Dependence
Keywords: Marijuana
Buspirone
Contingency management
Motivational enhancement therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-03
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percent Marijuana-negative Urine Drug Screens (UDS)
timeFrame: Participants provided a once-weekly urine sample for twelve weeks
Secondary outcomes:
measure: Retention in the Study
timeFrame: participants were followed for twelve weeks
measure: Marijuana Craving
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aimee McRae-Clark, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: