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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00360191
Enrollment
81
Registered
2006-08-04
Start date
2004-04-30
Completion date
2007-12-31
Last updated
2012-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Abuse

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.

Interventions

DRUGBuspirone
PROCEDUREMotivational enhancement therapy

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026