An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
|ClinicalTrials.gov Identifier: NCT00628927|
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : August 30, 2013
Last Update Posted : December 30, 2015
|Condition or disease||Phase|
|Stimulant Dependence||Phase 3|
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.
|Study Type :||Observational|
|Actual Enrollment :||217 participants|
|Observational Model:||Case Control|
|Official Title:||An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers|
|Study Start Date :||February 2008|
|Primary Completion Date :||October 2009|
|Study Completion Date :||March 2010|
METH and/or cocaine dependent group
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
The Non METH and/or cocaine dependent group participants are normal controls recruited from the community.
- Stroop Color-word Task [ Time Frame: Single study visit ]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.
- Barrett Impulsiveness Scale Version 11 (BIS-11) [ Time Frame: Single study visit ]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).
- Tail Length From the Comet Assay for Oxidative Damage [ Time Frame: Single study visit ]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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628927
|United States, Florida|
|Gateway Community Services|
|Jacksonville, Florida, United States, 32211|
|United States, Ohio|
|Columbus, Ohio, United States, 43207|
|United States, Oregon|
|Willamette Family Treatment Services|
|'Eugene, Oregon, United States, 97402|
|Portland, Oregon, United States, 97292|
|United States, Texas|
|Nexus Recovery Center|
|Dallas, Texas, United States, 75228|
|United States, Washington|
|Recovery Centers of King County|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Theresa Winhusen, Ph.D.||University of Cincinnati|