Clinical trial NCT00744601: Impulsivity, Neural Deficits and Cocaine Addiction
Official title: Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cocaine Dependence
Keywords: impulsivity
cocaine dependence
relapse
neuroimaging
functional magnetic resonance imaging (fMRI)
single photon emission computed tomography (SPECT)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Dallas VA Medical Center
First posted: 2008-09-01
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls.
timeFrame: 2 weeks
measure: In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Assess the predictive validity of self-report measures of impulsive relapse.
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas, Divison on Addictions
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Bryon Adinoff, MD
role: PRINCIPAL_INVESTIGATOR
References: