Impulsivity, Neural Deficits and Cocaine Addiction - Full Text View

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

Drug Information available for:

8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional

Official Title:	Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

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

Biospecimen Description:

urine, blood, plasma, and erythrocytes

Estimated Enrollment:	80
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2012

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744601

Contacts


Contact: Bryon Adinoff, MD	214-645-6975 ext 6990	bryon.adinoff@utsouthwestern.edu

Contact: Jacquelyn A Braud, MA	214-645-6975 ext 6901	jacquelyn.braud@utsouthwestern.edu

Locations


United States, Texas
	UT Southwestern Medical Center at Dallas, Divison on Addictions	Recruiting
	Dallas, Texas, United States, 75390-8564
	Contact: Bryon Adinoff, MD 214-645-6975 ext 6990 bryon.adinoff@utsouthwestern.edu
	Contact: Jacquelyn A Braud, MA 214-645-6975 ext 6901 jacquelyn.braud@utsouthwestern.edu
	Principal Investigator: Bryon Adinoff, MD

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

Principal Investigator home page This link exits the ClinicalTrials.gov site

Responsible Party:	UT Southwestern Medical Center at Dallas and VA North Texas Health Care System ( Bryon Adinoff, MD, Professor )
Study ID Numbers:	DA023203, 1RO1DA023203-01
First Received:	June 19, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744601
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)

Study placed in the following topic categories:

Cocaine-Related Disorders

Behavior, Addictive

Dopamine

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Cardiovascular Agents

Pharmacologic Actions

Anesthetics, Local

Sensory System Agents

Therapeutic Uses

Vasoconstrictor Agents

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	University of Texas Southwestern Medical Center National Institute on Drug Abuse (NIDA) Dallas VA Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00744601