Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of

Status Completed

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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00218075
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact
Status	Completed
Phase	Phase 2
Start date	March 2000
Completion date	October 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01526538` - Improving Learning-based Treatment of Cocaine Dependence With Medication	Phase 2
Completed	`NCT00877435` - Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial	N/A
Completed	`NCT00430690` - Acoustic Startle Reduction In Cocaine Dependence
Completed	`NCT00217997` - Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals	N/A
Active, not recruiting	`NCT00094315` - Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1	Phase 1
Terminated	`NCT00142883` - The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3	N/A
Completed	`NCT00218348` - Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo	Phase 2
Completed	`NCT00158132` - Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2	Phase 2
Completed	`NCT00142844` - Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1	Phase 2
Completed	`NCT00000294` - Effects of Carvedilol on Cocaine Use in Humans - 11	Phase 2
Completed	`NCT00015054` - Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3	Phase 2
Completed	`NCT00000308` - Dextroamphetamine-Cocaine Behavioral Intervention - 5	Phase 2
Completed	`NCT00000280` - Glutaminergic Agents for Cocaine Abuse - 5	Phase 1
Completed	`NCT00000277` - Mazindol for Cocaine Abuse - 2	Phase 2
Terminated	`NCT00000276` - Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Phase 1
Completed	`NCT00000306` - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3	Phase 2
Completed	`NCT00000314` - M-CPP and Fenfluramine in Cocaine Addicts - 3	Phase 2
Completed	`NCT00000282` - Pemoline for Cocaine Abuse - 7	Phase 2
Completed	`NCT00000278` - Disulfiram for Cocaine-Alcohol Abuse - 3	Phase 2
Completed	`NCT00000281` - Pharmacotherapy for Schizophrenic Drug Users - 6	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms