Impulsivity, Neural Deficits and Cocaine Addiction

Cocaine Dependence Clinical Trial

Official title:

Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744601
• Other study ID #: DA023203
• Secondary ID: 1RO1DA023203-01
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: December 31, 2012
• Start date: April 2007
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Impulsive Behavior

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center at Dallas, Divison on Addictions	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Dallas VA Medical Center, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls.		2 weeks	No
Primary	In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment.		6 months	No
Secondary	Assess the predictive validity of self-report measures of impulsive relapse.		6 months	No