Impulsivity, Neural Deficits and Cocaine Addiction

This study has been completed.
Sponsor:
Collaborators:
Dallas VA Medical Center
Information provided by (Responsible Party):
Bryon H Adinoff, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00744601
First received: June 19, 2008
Last updated: December 31, 2012
Last verified: December 2012
  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 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 ] [ Designated as safety issue: No ]
  • In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the predictive validity of self-report measures of impulsive relapse. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Dallas VA Medical Center
Investigators
Principal Investigator: Bryon Adinoff, MD UT Southwestern Medical Center at Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: Bryon H Adinoff, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00744601     History of Changes
Other Study ID Numbers: DA023203, 1RO1DA023203-01
Study First Received: June 19, 2008
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 29, 2014