Impulsivity, Neural Deficits and Cocaine Addiction

This study has been completed.

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT00744601

First received: June 19, 2008

Last updated: December 31, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2008

Last Updated Date

December 31, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00744601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impulsivity, Neural Deficits and Cocaine Addiction

Official Title ^ICMJE

Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

Brief Summary

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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

urine, blood, plasma, and erythrocytes

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.

Condition ^ICMJE

Cocaine Dependence

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

1
Patients with Cocaine Addiction
2
Healthy Control Volunteers

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00744601

Other Study ID Numbers ^ICMJE

DA023203, 1RO1DA023203-01

Has Data Monitoring Committee

Responsible Party

Bryon H Adinoff, University of Texas Southwestern Medical Center

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)
Dallas VA Medical Center

Investigators ^ICMJE

Principal Investigator:

Bryon Adinoff, MD

UT Southwestern Medical Center at Dallas

Information Provided By

University of Texas Southwestern Medical Center

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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