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A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence
This study has been completed.
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00360191
  Purpose

The purpose of this study is to determine if buspirone combined with motivational enhancement therapy is effective in reducing marijuana use in marijuana-dependent adults.


Condition Intervention Phase
Marijuana Abuse
Drug: Buspirone
Procedure: Motivational enhancement therapy
Phase II

MedlinePlus related topics: Marijuana
Drug Information available for: Cannabis GW-1000 Buspirone Buspirone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence

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

Enrollment: 81
Study Start Date: April 2004
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men and women, 18 years of age to 65 years of age.
  2. Meet DSM-IV criteria for marijuana dependence.
  3. All subjects will agree to and sign a written, IRB-approved informed consent.
  4. Subjects must live within a 60-mile radius of Charleston, SC, in order to improve study visit compliance.
  5. Subjects must be willing to identify collateral individuals for contact purposes to facilitate follow-up appointments.

Exclusion Criteria:

  1. Individuals meeting DSM-IV dependence for a substance other than marijuana with the exception of nicotine and caffeine. Dependence on nicotine and caffeine will be allowed since dependence on these substances commonly co-occurs with marijuana dependence and excluding these individuals would compromise study recruitment.
  2. Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care.
  3. Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications.
  4. Individuals who present significant suicidal risk.
  5. Individuals with significant cognitive impairment, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments.
  6. Individuals currently receiving benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of buspirone treatment.
  7. Pregnant or nursing women, or women who refuse to use adequate birth control, as buspirone has not been approved for use in pregnancy.
  8. Individuals without stable housing, as contacting these individuals would be difficult.
  9. Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis).
  10. Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360191

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Investigators
Principal Investigator: Aimee L McRae, PharmD Medical University of South Carolina
  More Information

Study ID Numbers: K23DA015440, K23DA015440
Study First Received: August 2, 2006
Last Updated: December 11, 2007
ClinicalTrials.gov Identifier: NCT00360191  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Buspirone
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Marijuana Abuse
Serotonin

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Tranquilizing Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anti-Anxiety Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009