Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals

Completed

• Conditions: Cocaine-Related Disorders; Cocaine Abuse

• Registration Number: NCT00217997
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 trial is to evaluate aspects of treatment response in cocaine dependent individuals.

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. The purpose of this study is to determine how impulsivity and prefrontal cortical function are related to treatment response in cocaine dependent individuals.

Participants in this study will complete four separate experiments, each with a different aim and testing panel \[cognitive function tests with and without functional magnetic resonance imaging (fMRI)\]. The first experiment will examine memory, attention, cognitive function, and impulsivity; the aim is to determine the relationship between impulsivity and cognitive function in cocaine dependent individuals receiving treatment. The second experiment will examine the relationship between impulsivity and the prefrontal cortical structure and function. Participants will complete an fMRI during the second experiment. The third experiment will consist of cognitive function tests and will examine the prefrontal cortex in relation to treatment response, based on four different treatments: 1) L-dopamine, 2) naltrexone, 3) modafinil, and 4) placebo. The fourth experiment will examine the effect of cocaine dependence treatment on prefrontal cortex, focusing on participants receiving modafinil.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Meets DSM-IV criteria for cocaine dependence
• Met inclusion criteria for other cocaine dependence studies within the center grant

Exclusion Criteria

• Current or history of DSM-IV Axis I disorders, other than substance abuse or dependence
• Lifetime diagnosis of alcohol dependence
• Serious non-psychiatric medical illness requiring ongoing medical treatment or one that affects the central nervous system
• Positive urine drug screen test for drugs of abuse other than cocaine at the time of study entry
• AIDS-defining illness
• Intelligence Quotient (IQ) below 70
• Pregnant
• Uses a pacemaker, metal or electromechanical implants, or metallic foreign bodies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fMRI brain activation	baseline	Baseline predictor of treatment response

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States