Buspirone Treatment for Marijuana Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00875836
First received: April 2, 2009
Last updated: June 2, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buspirone Treatment for Marijuana Dependence

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Percent marijuana-positive urine drug screens [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first negative urine screen [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Retention in the study [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Marijuana craving and withdrawal [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Buspirone
Drug: Buspirone
30 mg capsules twice daily
Other Name: Buspar
Placebo Comparator: 2
Placebo
Drug: Placebo
30 mg capsules twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Aimee McRae-Clark, Pharm.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Aimee McRae-Clark, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00875836     History of Changes
Other Study ID Numbers: R01DA026782, R01DA026782, DPMCDA
Study First Received: April 2, 2009
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Marijuana
Buspirone
Contingency management
Motivational enhancement therapy

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

ClinicalTrials.gov processed this record on October 30, 2014