Buspirone Treatment for Marijuana Dependence - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00875836

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Urine and Urination

Drug Information available for: Buspirone hydrochloride Buspirone

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Buspirone	Drug: Buspirone 30 mg capsules twice daily
2: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875836

Contacts

Contact: Kathleen White, BS

843-792-1433

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Aimee McRae-Clark, Pharm.D.

Medical University of South Carolina

More Information

No publications provided

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

Keywords provided by National Institute on Drug Abuse (NIDA):

Marijuana
Buspirone
Contingency management
Motivational enhancement therapy

Study placed in the following topic categories:

Serotonin Agonists
Buspirone
Neurotransmitter Agents
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin
Anti-Anxiety Agents
Marijuana Abuse
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Marijuana Abuse

Pharmacologic Actions
Buspirone
Serotonin Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009