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

May 5, 2017 updated by: The University of Texas Health Science Center, Houston

Impulsivity, Brain Function and Substance Abuse Treatment

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cocaine Dependent Subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI brain activation
Time Frame: baseline
Baseline predictor of treatment response
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA)
University of Texas

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-09262-6
  • DPMC (Other Identifier: NIDA)
  • 5P50DA009262-17 (U.S. NIH Grant/Contract)
  • P50-09262-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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