Buspirone Treatment for Marijuana Dependence

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status and phase

Completed
Phase 4

Conditions

Marijuana Dependence

Treatments

Drug: Buspirone
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00875836
DPMCDA
R01DA026782 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

Enrollment

175 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Must meet DSM-IV criteria for marijuana dependence.
  • Must be between the ages of 18 and 65 years.
  • If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
  • Must consent to random assignment, and be willing to commit to psychosocial behavioral and medication treatment.
  • Must be able to read and provide informed consent.

Exclusion criteria

  • Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
  • Must not have a history of or current psychotic disorder, bipolar disorder, or eating disorder.
  • Must not pose a current suicidal or homicidal risk.
  • Must not meet current criteria for major depression.
  • Must not have evidence or history of serious hematologic, endocrine, cardiovascular, pulmonary, renal, gastrointestinal or neurologic disease.
  • Must not require concomitant therapy with psychotropic medication.
  • Must not be currently dependent on other substances, with the exception of nicotine or caffeine.
  • Hypersensitivity to buspirone or any other product component.
  • Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

175 participants in 2 patient groups, including a placebo group

Buspirone
Experimental group
Description:
Buspirone
Treatment:
Drug: Buspirone
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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