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Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1

Primary Purpose

Marijuana Abuse, Mood Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buspirone
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring Marijuana, Mood Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Drug use; measured at Weeks 12 and 16

Secondary Outcome Measures

Anxiety; measured at Week 12
Craving; measured at Week 12
Withdrawal symptoms; measured at Week 12

Full Information

First Posted
September 6, 2005
Last Updated
October 8, 2015
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00149617
Brief Title
Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1
Official Title
Career Training in Marijuana Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
This study will assess the effectiveness of a combination of buspirone and motivational interviewing therapy in the treatment of marijuana dependence.
Detailed Description
Marijuana dependence is one of the most common substance-related disorders in the United States. Despite its prevalence, there is a lack of clinical research addressing treatments for marijuana dependence. Research has shown that marijuana abuse is associated with affective disorders. This may be caused by repeated use for relief from anxiety. The use of an anxiolytic agent, a drug that relieves anxiety, may help treat marijuana dependence. Motivational enhancement therapy has been shown to reduce marijuana use. Therefore, it is likely that buspirone, which is an anxiolytic agent, combined with motivational enhancement therapy will prove beneficial in treating marijuana dependence. This study will assess the effectiveness of a combination of buspirone and motivational interviewing in the treatment of marijuana dependence. This double-blind study will last a total of 16 weeks. Participants will be randomly assigned to receive either buspirone or placebo for a period of 12 weeks. There will be one follow-up appointment 4 weeks post-intervention. Baseline assessments will include a physical exam and urine and blood tests. Study visits will occur weekly throughout treatment in order to monitor compliance, assess adverse affects, and obtain substance use data. Mood assessment scales, marijuana craving questionnaires, and a withdrawal symptom checklist will be used to gather the data. Urine drug screens will be collected weekly to test for marijuana use. In addition to this, the presence of opioids, cocaine, amphetamines, and benzodiazepines will be tested at baseline, Weeks 6 and 12, and at follow-up. A 10-day supply of medication will be dispensed to participants each week. Meetings for motivational enhancement therapy will last 30 to 90 minutes each and will occur at baseline, Week 2, and Week 4. Participants' perceived quality of life will be measured at baseline and Weeks 6 and 12 to determine the effect of buspirone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse, Mood Disorders
Keywords
Marijuana, Mood Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buspirone
Primary Outcome Measure Information:
Title
Drug use; measured at Weeks 12 and 16
Secondary Outcome Measure Information:
Title
Anxiety; measured at Week 12
Title
Craving; measured at Week 12
Title
Withdrawal symptoms; measured at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Mcrae, Pharm.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1

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