Skip to main content
OpenTrials
Completed

NCT Number: NCT00875836

Buspirone Treatment for Marijuana Dependence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Marijuana Dependence Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Buspirone

Drug

Flexible dose, up to 60 mg daily

Other names: Buspar

Placebo

Drug

Flexible dose, up to 60 mg daily

Primary outcomes

  1. Percent Marijuana-negative Urine Drug Screens (UDS)

    Time frame: Participants provided a once-weekly urine sample for twelve weeks

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

Secondary outcomes

  1. Retention in the Study

    Time frame: participants were followed for twelve weeks

    Number of days subjects remained active in the study

  2. Marijuana Craving

    Time frame: 8 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Apr 3, 2009
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.