Buspirone Treatment for Marijuana Dependence

Marijuana Dependence Clinical Trial

Official title:

Buspirone Treatment for Marijuana Dependence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00875836
• Other study ID #: R01DA026782
• Secondary ID: R01DA026782DPMCD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 2, 2009
• Last updated: February 10, 2016
• Start date: September 2009
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: May 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• Buspirone
Flexible dose, up to 60 mg daily
• Placebo
Flexible dose, up to 60 mg daily

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Marijuana-negative Urine Drug Screens (UDS)	Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.	Participants provided a once-weekly urine sample for twelve weeks	No
Secondary	Retention in the Study	Number of days subjects remained active in the study	participants were followed for twelve weeks	No
Secondary	Marijuana Craving	The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.	8 Weeks	No