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Completed

NCT Number: NCT00218075

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Science Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levodopa

Drug

Carbidopa

Drug

Clinical management

Behavioral

Relapse Prevention Therapy

Behavioral

Contingency Management

Behavioral

Primary outcomes

  1. Cocaine use

Secondary outcomes

  1. Medication compliance

  2. treatment retention

  3. severity of addiction-related problems

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Texas

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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