Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence
Primary Purpose
Cocaine Abuse, Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levodopa
Carbidopa
Clinical Management
Relapse Prevention Therapy
Contingency Management
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Abuse focused on measuring Cocaine addiction, cocaine treatment
Eligibility Criteria
Inclusion Criteria: Meets DSM-IV criteria for current cocaine dependence Provides at least one positive urine test for cocaine during study screening Good general health, based on a physical exam, lab tests, and an electrocardiogram Reads and writes English at a sixth grade level Exclusion Criteria: Current Axis I depressive, psychotic, or anxiety disorder Currently in jail Pregnant or breastfeeding Requires certain medications
Sites / Locations
- University of Texas Health Science Center
Outcomes
Primary Outcome Measures
Cocaine use
Secondary Outcome Measures
Medication compliance
treatment retention
severity of addiction-related problems
Full Information
NCT ID
NCT00218075
First Posted
September 16, 2005
Last Updated
January 4, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA), University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00218075
Brief Title
Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence
Official Title
Behavioral Strategies to Maximize the Efficacy of Pharmacotherapy for Cocaine Dependence: Relapse Prevention With Contingency Management Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA), University of Texas
4. Oversight
5. Study Description
Brief Summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In addition, this study will examine the effects of incentive rewards for treatment compliance.
Detailed Description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Levodopa is a medication that is used alone or in combination with carbidopa to treat Parkinson's disease. The purpose of this study is to determine the possible interactions between behavioral interventions and carbidopa/levodopa in order to treat cocaine dependent individuals.
This study will last 12 weeks and will involve two phases. The first phase will include three therapy conditions: 1) clinical management only, 2) clinical management and relapse prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency management. All of the conditions in the first phase will be evaluated incrementally under active and placebo conditions while participants receive carbidopa/levodopa.
The second phase of the study will examine the contingency management procedure applications. Each of the three contingency management procedure applications targets specific behaviors that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits. Participants will receive relapse prevention therapy combined with a contingency management procedure that targets clinic attendance, medication compliance, and cocaine abstinence. Study visits will occur weekly throughout the study. In addition, participants will complete a one-year follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse, Cocaine-Related Disorders
Keywords
Cocaine addiction, cocaine treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levodopa
Intervention Type
Drug
Intervention Name(s)
Carbidopa
Intervention Type
Behavioral
Intervention Name(s)
Clinical Management
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention Therapy
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Primary Outcome Measure Information:
Title
Cocaine use
Secondary Outcome Measure Information:
Title
Medication compliance
Title
treatment retention
Title
severity of addiction-related problems
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV criteria for current cocaine dependence
Provides at least one positive urine test for cocaine during study screening
Good general health, based on a physical exam, lab tests, and an electrocardiogram
Reads and writes English at a sixth grade level
Exclusion Criteria:
Current Axis I depressive, psychotic, or anxiety disorder
Currently in jail
Pregnant or breastfeeding
Requires certain medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence
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