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

NCT ID: NCT00218075

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Cocaine Abuse Cocaine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levodopa

Intervention Type DRUG

Carbidopa

Intervention Type DRUG

Clinical Management

Intervention Type BEHAVIORAL

Relapse Prevention Therapy

Intervention Type BEHAVIORAL

Contingency Management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Joy Schmitz

Professor - Psy, Behavioral Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Grabowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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P50DA009262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50-09262-9

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-09262-9

Identifier Type: -

Identifier Source: org_study_id

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