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Impulsivity, Neural Deficits and Cocaine Addiction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00744601
First Posted: September 1, 2008
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Dallas VA Medical Center
Information provided by (Responsible Party):
Bryon H Adinoff, University of Texas Southwestern Medical Center
  Purpose
The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.

Condition
Cocaine Dependence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

Resource links provided by NLM:


Further study details as provided by Bryon H Adinoff, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls. [ Time Frame: 2 weeks ]
  • In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Assess the predictive validity of self-report measures of impulsive relapse. [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
urine, blood, plasma, and erythrocytes

Enrollment: 90
Study Start Date: April 2007
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with Cocaine Addiction
2
Healthy Control Volunteers

Detailed Description:
This study is designed to explore putative differences in impulsive behaviors and decision making in cocaine-addicted and healthy control subjects using functional magnetic resonance imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations in measures of impulsivity and decision-making when compared to healthy controls. That is, cocaine-addicted subjects will show both decreased activation and decreased resting measures of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity and decision-making. Furthermore, neurocognitive and neural deficits associated with impulsivity and decision-making will be associated with each other and with measures indicative of an impulsive relapse and altered decision making.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from residential treatment programs at the VA North Texas Health Care System, Nexus Recovery Inc., and Homeward Bound Inc. Healthy controls will be recruited from the Greater Dallas community.
Criteria

Inclusion Criteria:

  • Cocaine-dependence (patient population) or no cocaine-dependence (control population).

Exclusion Criteria:

  • Other medical or psychiatric disorders that may effect neural functioning.
  • Medications that may effect neural functioning.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744601


Locations
United States, Texas
UT Southwestern Medical Center at Dallas, Divison on Addictions
Dallas, Texas, United States, 75390-8564
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Dallas VA Medical Center
Investigators
Principal Investigator: Bryon Adinoff, MD UT Southwestern Medical Center at Dallas
  More Information

Responsible Party: Bryon H Adinoff, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00744601     History of Changes
Other Study ID Numbers: DA023203
1R01DA023203-01 ( U.S. NIH Grant/Contract )
First Submitted: June 19, 2008
First Posted: September 1, 2008
Last Update Posted: January 3, 2013
Last Verified: December 2012

Keywords provided by Bryon H Adinoff, University of Texas Southwestern Medical Center:
impulsivity
cocaine dependence
relapse
neuroimaging
functional magnetic resonance imaging (fMRI)
single photon emission computed tomography (SPECT)

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


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