Overview

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

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Buspirone
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.