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

NCT00628927 | Completed Results DMC

• 3 other identifiers: NIDA-CTN-0031A5U10DA013732U10DA013732
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Stimulant Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Barrett Impulsiveness Scale Version 11 (BIS-11)

  Single study visit

• Tail Length From the Comet Assay for Oxidative Damage

  Single study visit

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• history of stroke
• history of a seizure disorder
• be 18 years of age or older
• be able to understand the study and provide written informed consent in English
• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

Gateway Community Services

Jacksonville, Florida, 32211, United States

Location

Maryhaven

Columbus, Ohio, 43207, United States

Location

Willamette Family Treatment Services

Eugene, Oregon, 97402, United States

Location

ChangePoint, Inc.

Portland, Oregon, 97292, United States

Location

Nexus Recovery Center

Dallas, Texas, 75228, United States

Location

Recovery Centers of King County

Seattle, Washington, 98122, United States

Location

Related Publications (2)

• 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.

  PMID: 22771145 RESULT

• 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.

  PMID: 23808868 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for the oxidative stress/damage analysis

Results Point of Contact

• Title: Dr. Theresa Winhusen
• Organization: University of Cincinnati

winhusen@carc.uc.edu

513-487-7800

Study Officials

• Theresa Winhusen, Ph.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 5, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2010
• Last Updated: December 30, 2015
• Results First Posted: August 30, 2013

Record last verified: 2015-12

Locations

US (6)