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

Stimulant Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628927
• Other study ID #: NIDA-CTN-0031A
• Secondary ID: 5U10DA013732U10D
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2008
• Last updated: December 1, 2015
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stimulant Dependence

Locations

Country	Name	City	State
United States	Willamette Family Treatment Services	'Eugene	Oregon
United States	Maryhaven	Columbus	Ohio
United States	Nexus Recovery Center	Dallas	Texas
United States	Gateway Community Services	Jacksonville	Florida
United States	ChangePoint, Inc.	Portland	Oregon
United States	Recovery Centers of King County	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No