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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Texas
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00217997
First received: September 16, 2005
Last updated: May 5, 2017
Last verified: May 2017
  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
Cocaine Abuse Cocaine-Related Disorders

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • fMRI brain activation [ Time Frame: baseline ]
    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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Institute on Drug Abuse (NIDA)
University of Texas
Investigators
Principal Investigator: Frederick G. Moeller, PhD University of Texas
  More Information

Additional Information:
Publications:

Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00217997     History of Changes
Other Study ID Numbers: NIDA-09262-6
5P50DA009262-17 ( U.S. NIH Grant/Contract )
P50-09262-6
DPMC
Study First Received: September 16, 2005
Last Updated: May 5, 2017

Keywords provided by The University of Texas Health Science Center, Houston:
cocaine abuse
Cocaine-Related Disorders

Additional relevant MeSH terms:
Substance-Related Disorders
Cocaine-Related Disorders
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 19, 2017