NCT00875836

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
8 days until next milestone

Results Posted

Study results publicly available

March 9, 2016

Completed
Last Updated

August 10, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

April 2, 2009

Results QC Date

September 21, 2015

Last Update Submit

July 8, 2016

Conditions

Marijuana Dependence

Keywords

MarijuanaBuspironeContingency managementMotivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

  • Percent Marijuana-negative Urine Drug Screens (UDS)

    Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.

    Participants provided a once-weekly urine sample for twelve weeks

Secondary Outcomes (2)

  • Retention in the Study

    participants were followed for twelve weeks

  • Marijuana Craving

    8 Weeks

Study Arms (2)

Buspirone

EXPERIMENTAL

Buspirone

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BuspironeDRUG

Flexible dose, up to 60 mg daily

Also known as: Buspar
Buspirone
PlaceboDRUG

Flexible dose, up to 60 mg daily

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Limitations and Caveats

Limitations included significant attrition during the course of the 12-week trial, difficulty with UCT interpretation due to the long excretion half-life of marijuana in urine, and likelihood that the genetic analysis was underpowered.

Results Point of Contact

Title
Dr. Aimee McRae-Clark
Organization
MUSC
mcraeal@musc.edu
843.792.5216

Study Officials

  • Aimee McRae-Clark, Pharm.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2014

Study Completion

March 1, 2016

Last Updated

August 10, 2016

Results First Posted

March 9, 2016

Record last verified: 2016-07

Locations

US(1)