Clinical trial NCT00628927: An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
Official title: An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stimulant Dependence
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-03-05
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroop Color-word Task
timeFrame: Single study visit
Secondary outcomes:
measure: Barrett Impulsiveness Scale Version 11 (BIS-11)
timeFrame: Single study visit
measure: Tail Length From the Comet Assay for Oxidative Damage
timeFrame: Single study visit
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Columbus
country: United States
facility: Maryhaven
state: Ohio
city: 'Eugene
country: United States
facility: Willamette Family Treatment Services
state: Oregon
city: Portland
country: United States
facility: ChangePoint, Inc.
state: Oregon
city: Dallas
country: United States
facility: Nexus Recovery Center
state: Texas
city: Seattle
country: United States
facility: Recovery Centers of King County
state: Washington
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.