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A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Motivational enhancement therapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy men and women, 18 years of age to 65 years of age. Meet DSM-IV criteria for marijuana dependence. All subjects will agree to and sign a written, IRB-approved informed consent. Subjects must live within a 60-mile radius of Charleston, SC, in order to improve study visit compliance. Subjects must be willing to identify collateral individuals for contact purposes to facilitate follow-up appointments. Exclusion Criteria: 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. 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. Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications. Individuals who present significant suicidal risk. Individuals with significant cognitive impairment, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments. Individuals currently receiving benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of buspirone treatment. Pregnant or nursing women, or women who refuse to use adequate birth control, as buspirone has not been approved for use in pregnancy. Individuals without stable housing, as contacting these individuals would be difficult. Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis). 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.

Sites / Locations

  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 2, 2006
Last Updated
January 10, 2012
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00360191
Brief Title
A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence
Official Title
A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Type
Procedure
Intervention Name(s)
Motivational enhancement therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women, 18 years of age to 65 years of age. Meet DSM-IV criteria for marijuana dependence. All subjects will agree to and sign a written, IRB-approved informed consent. Subjects must live within a 60-mile radius of Charleston, SC, in order to improve study visit compliance. Subjects must be willing to identify collateral individuals for contact purposes to facilitate follow-up appointments. Exclusion Criteria: 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. 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. Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications. Individuals who present significant suicidal risk. Individuals with significant cognitive impairment, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments. Individuals currently receiving benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of buspirone treatment. Pregnant or nursing women, or women who refuse to use adequate birth control, as buspirone has not been approved for use in pregnancy. Individuals without stable housing, as contacting these individuals would be difficult. Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee L McRae, PharmD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence

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