Buspirone Treatment for Marijuana Dependence
This study is currently recruiting participants.
Verified April 2013 by Medical University of South Carolina
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00875836
First received: April 2, 2009
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Marijuana Dependence |
Drug: Buspirone Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Buspirone Treatment for Marijuana Dependence |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
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: | 176 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Buspirone
|
Drug: Buspirone
30 mg capsules twice daily
Other Name: Buspar
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
30 mg capsules twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875836
Contacts
| Contact: Amanda Wagner, MA, LPC | 843-792-0484 | wagne@musc.edu |
Locations
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Ricardo Cantu 843-792-8894 | |
Sponsors and Collaborators
Medical University of South Carolina
Investigators
| Principal Investigator: | Aimee McRae-Clark, Pharm.D. | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | Aimee McRae-Clark, Associate Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00875836 History of Changes |
| Other Study ID Numbers: | R01DA026782, R01DA026782, DPMCDA |
| Study First Received: | April 2, 2009 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
|
Marijuana Buspirone Contingency management Motivational enhancement therapy |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders Buspirone Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013