Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence

Cocaine-Related Disorders Clinical Trial

Official title:

Behavioral Strategies to Maximize the Efficacy of Pharmacotherapy for Cocaine Dependence: Relapse Prevention With Contingency Management Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218075
• Other study ID #: NIDA-09262-9
• Secondary ID: P50DA009262P50-0
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 4, 2016
• Start date: March 2000
• Est. completion date: October 2007

Study information

• Verified date: January 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine-Related Disorders

Intervention

Drug:
• Levodopa

• Carbidopa

Behavioral:
• Clinical Management

• Relapse Prevention Therapy

• Contingency Management

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA), University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine use
Secondary	Medication compliance
Secondary	treatment retention
Secondary	severity of addiction-related problems

External Links

•   Click here for more information on the University of Texas Health Science Center Treatment Research Clinic