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

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Information provided by (Responsible Party):
F. Gerald Moeller, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00217997
First received: September 16, 2005
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 Phase
Cocaine Abuse
Cocaine-Related Disorders
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impulsivity, Brain Function and Substance Abuse Treatment

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • fMRI brain activation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Baseline predictor of treatment response


Enrollment: 192
Study Start Date: September 2005
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cocaine Dependent Subjects

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217997

Locations
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Texas
Investigators
Principal Investigator: Frederick G. Moeller, PhD University of Texas
  More Information

Publications:

Responsible Party: F. Gerald Moeller, Professor - Psy, Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00217997     History of Changes
Other Study ID Numbers: NIDA-09262-6, 5P50DA009262-17, P50-09262-6, DPMC
Study First Received: September 16, 2005
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Impulsive Behavior
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014