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

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

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.

Study Overview

• Status: Completed
• Conditions: Stimulant Dependence

Detailed Description

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:

1. 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;
2. neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;
3. oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,
4. oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and
5. exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.

• Study Type: Observational
• Enrollment (Actual): 217

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32211
      • Gateway Community Services
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Maryhaven
  • Oregon
    • 'Eugene, Oregon, United States, 97402
      • Willamette Family Treatment Services
    • Portland, Oregon, United States, 97292
      • ChangePoint, Inc.
  • Texas
    • Dallas, Texas, United States, 75228
      • Nexus Recovery Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Recovery Centers of King County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Theresa Winhusen, Ph.D., University of Cincinnati

Publications and helpful links

General Publications

• Winhusen TM, Somoza EC, Lewis DF, Kropp FB, Horigian VE, Adinoff B. Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response. Drug Alcohol Depend. 2013 Jan 1;127(1-3):94-100. doi: 10.1016/j.drugalcdep.2012.06.017. Epub 2012 Jul 6.
• Winhusen T, Walker J, Brigham G, Lewis D, Somoza E, Theobald J, Somoza V. Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction. Am J Drug Alcohol Abuse. 2013 Jul;39(4):227-34. doi: 10.3109/00952990.2013.798663. Epub 2013 Jun 28.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: March 3, 2008
• First Submitted That Met QC Criteria: March 3, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NIDA-CTN-0031A; U10DA013732 (U.S. NIH Grant/Contract); 5U10DA013732 (U.S. NIH Grant/Contract)