Impulsivity, Neural Deficits and Cocaine Addiction

December 31, 2012 updated by: Bryon H Adinoff, University of Texas Southwestern Medical Center

Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-8564
        • UT Southwestern Medical Center at Dallas, Divison on Addictions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with Cocaine Addiction
2
Healthy Control Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the predictive validity of self-report measures of impulsive relapse.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Bryon Adinoff, MD, UT Southwestern Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

December 31, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA023203
  • 1R01DA023203-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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