NCT00149617

Brief Summary

This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 9, 2015

Status Verified

December 1, 2007

First QC Date

September 6, 2005

Last Update Submit

October 8, 2015

Conditions

Marijuana AbuseMood Disorders

Keywords

MarijuanaMood Disorder

Outcome Measures

Primary Outcomes (1)

  • Drug use; measured at Weeks 12 and 16

Secondary Outcomes (3)

  • Anxiety; measured at Week 12

  • Craving; measured at Week 12

  • Withdrawal symptoms; measured at Week 12

Interventions

BuspironeDRUG

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV criteria for marijuana dependence
  • Lives within 60 miles of the study site
  • Willing to provide collateral individuals for contact purposes
  • Willing to use an effective form of contraception throughout the study

You may not qualify if:

  • Meets DSM-IV criteria for dependence upon a substance other than marijuana, nicotine, or caffeine
  • Meets DSM-IV criteria for a history of schizophrenia or another non-affective psychotic disorder or bipolar disorder
  • Meets DSM-IV criteria for current major depressive disorder or eating disorder
  • Significant cognitive impairment
  • Currently taking benzodiazepines, antidepressant, or antipsychotic medications
  • Major medical illnesses (e.g., HIV, kidney failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
  • Not in stable housing
  • Pregnant or breastfeeding

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 AbuseMood Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Aimee Mcrae, Pharm.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2004

Study Completion

December 1, 2007

Last Updated

October 9, 2015

Record last verified: 2007-12

Locations

US(1)