Buspirone Treatment for Marijuana Dependence
This study is currently recruiting participants.
Verified April 2013 by Medical University of South Carolina
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
First received: April 2, 2009
Last updated: April 2, 2013
Last verified: April 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Buspirone Treatment for Marijuana Dependence
Primary Outcome Measures:
- Percent marijuana-positive urine drug screens [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first negative urine screen [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Retention in the study [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Marijuana craving and withdrawal [ Time Frame: Weekly ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
30 mg capsules twice daily
Other Name: Buspar
Placebo Comparator: 2
30 mg capsules twice daily
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875836
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425 |
|Contact: Ricardo Cantu 843-792-8894 |
Medical University of South Carolina
||Aimee McRae-Clark, Pharm.D.
||Medical University of South Carolina
No publications provided
||Aimee McRae-Clark, Associate Professor, Medical University of South Carolina
History of Changes
|Other Study ID Numbers:
||R01DA026782, R01DA026782, DPMCDA
|Study First Received:
||April 2, 2009
||April 2, 2013
||United States: Food and Drug Administration
Keywords provided by Medical University of South Carolina:
Motivational enhancement therapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Serotonin Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents