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Buspirone Treatment for Marijuana Dependence

Primary Purpose

Marijuana Dependence

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Buspirone

Placebo

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring Marijuana, Buspirone, Contingency management, Motivational enhancement therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Buspirone

Placebo

Arm Description

Buspirone

Placebo

Outcomes

Primary Outcome Measures

Percent Marijuana-negative Urine Drug Screens (UDS)

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Secondary Outcome Measures

Retention in the Study

Number of days subjects remained active in the study

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.

Full Information

NCT ID

NCT00875836

First Posted

April 2, 2009

Last Updated

July 8, 2016

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00875836

Brief Title

Buspirone Treatment for Marijuana Dependence

Official Title

Buspirone Treatment for Marijuana Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marijuana Dependence

Keywords

Marijuana, Buspirone, Contingency management, Motivational enhancement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

175 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buspirone

Arm Type

Experimental

Arm Description

Buspirone

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Buspirone

Other Intervention Name(s)

Buspar

Intervention Description

Flexible dose, up to 60 mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Flexible dose, up to 60 mg daily

Primary Outcome Measure Information:

Title

Percent Marijuana-negative Urine Drug Screens (UDS)

Description

Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

Time Frame

Participants provided a once-weekly urine sample for twelve weeks

Secondary Outcome Measure Information:

Title

Retention in the Study

Description

Number of days subjects remained active in the study

Time Frame

participants were followed for twelve weeks

Title

Marijuana Craving

Description

Time Frame

8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aimee McRae-Clark, Pharm.D.

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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Buspirone Treatment for Marijuana Dependence

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