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Completed

NCT Number: NCT00628927

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

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Key information

Conditions

Stimulant Dependence

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gateway Community Services, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 5, 2008
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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