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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT00217997
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), University of Texas (Other)
192
1
88
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    192 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impulsivity, Brain Function and Substance Abuse Treatment
    Study Start Date :
    Sep 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. fMRI brain activation [baseline]

      Baseline predictor of treatment response

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Frederick G. Moeller, PhD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT00217997
    Other Study ID Numbers:
    • NIDA-09262-6
    • 5P50DA009262-17
    • P50-09262-6
    • DPMC
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by The University of Texas Health Science Center, Houston
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 9, 2017