An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.

Detailed Description
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The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether: performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers; neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers; oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers, oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.

Official Title
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An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers

Conditions
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Stimulant Dependence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (METH and/or Cocaine Dependent Group): be randomized into the CTN-0031 (STAGE-12) trial current abuse or dependence for METH and/or cocaine endorse METH and/or cocaine as the primary drug of choice able to correctly distinguish the colored stimuli on the Stoop task. Exclusion Criteria (METH and/or Cocaine Dependent Group): history of stroke history of a seizure disorder Inclusion Criteria (Non-METH and/or Cocaine Dependent Group): be 18 years of age or older be able to understand the study and provide written informed consent in English Exclusion Criteria (Non-METH and/or Cocaine Dependent Group): history of stroke history of a seizure disorder positive urine toxicology screen screen positive for Major Depressive Syndrome, other Depressive Syndrome, Panic Syndrome, or other Anxiety Syndrome meet criteria for ADHD have HIV/AIDS history of an injury in which consciousness was lost for more than 30 minutes meet DSM-IV criteria for dependence (either current or lifetime) for any psychoactive substance other than nicotine or for abuse (both current and lifetime) for any psychoactive substance other than nicotine or for alcohol for which a life-time history of abuse is allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| METH and/or cocaine dependent group<br>The METH and/or cocaine dependent group were also enrolled in CTN0031 (NCT00573183) and seeking treatment. This group will be analyzed based on whether or not they completed treatment as defined by the study. | |
| Non METH and/or cocaine dependent group<br>The Non METH and/or cocaine dependent group participants are normal controls recruited from the community. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop Color-word Task | The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial. | Single study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barrett Impulsiveness Scale Version 11 (BIS-11) | The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from Rarely/Never to Almost Always/Always and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90). | Single study visit | 
| Tail Length From the Comet Assay for Oxidative Damage | The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage. | Single study visit |