Buspirone Treatment for Marijuana Dependence

NCT ID: NCT00875836

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Marijuana Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Buspirone

Buspirone

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: DRUG

Flexible dose, up to 60 mg daily

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Flexible dose, up to 60 mg daily

Interventions

Buspirone

Flexible dose, up to 60 mg daily

Intervention Type: DRUG

Placebo

Flexible dose, up to 60 mg daily

Intervention Type: DRUG

Other Intervention Names

Buspar

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aimee McRae-Clark

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aimee McRae-Clark, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

R01DA026782

Identifier Type: NIH

Identifier Source: secondary_id

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DPMCDA

Identifier Type: -

Identifier Source: secondary_id

R01DA026782

Identifier Type: NIH

Identifier Source: org_study_id

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