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Buspirone Treatment for Marijuana Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875836
First Posted: April 3, 2009
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buspirone Treatment for Marijuana Dependence

Resource links provided by NLM:


Further study details as provided by Aimee McRae-Clark, Medical University of South Carolina:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Retention in the Study [ Time Frame: participants were followed for twelve weeks ]
    Number of days subjects remained active in the study

  • 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.


Enrollment: 175
Study Start Date: September 2009
Study Completion Date: March 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buspirone
Buspirone
Drug: Buspirone
Flexible dose, up to 60 mg daily
Other Name: Buspar
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Flexible dose, up to 60 mg daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875836


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Aimee McRae-Clark, Pharm.D. Medical University of South Carolina
  More Information

Responsible Party: Aimee McRae-Clark, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00875836     History of Changes
Other Study ID Numbers: R01DA026782 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: April 2, 2009
First Posted: April 3, 2009
Results First Submitted: September 21, 2015
Results First Posted: March 9, 2016
Last Update Posted: August 10, 2016
Last Verified: July 2016

Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
Marijuana
Buspirone
Contingency management
Motivational enhancement therapy

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action