A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence
This study has been completed.
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00360191
First received: August 2, 2006
Last updated: January 10, 2012
Last verified: December 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
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
Medical University of South Carolina
Investigators
| Principal Investigator: | Aimee L McRae, PharmD | Medical University of South Carolina |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00360191 History of Changes |
| Other Study ID Numbers: | K23DA015440, K23DA015440 |
| Study First Received: | August 2, 2006 |
| Last Updated: | January 10, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders Buspirone Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013