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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00628927
First received: March 3, 2008
Last updated: July 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Phase
Stimulant Dependence
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Stroop Color-word Task [ Time Frame: Single study visit ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Barrett Impulsiveness Scale Version 11 (BIS-11) [ Time Frame: Single study visit ] [ Designated as safety issue: No ]
    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).

  • Tail Length From the Comet Assay for Oxidative Damage [ Time Frame: Single study visit ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood sample for the oxidative stress/damage analysis


Enrollment: 217
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628927

Locations
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32211
United States, Ohio
Maryhaven
Columbus, Ohio, United States, 43207
United States, Oregon
Willamette Family Treatment Services
'Eugene, Oregon, United States, 97402
ChangePoint, Inc.
Portland, Oregon, United States, 97292
United States, Texas
Nexus Recovery Center
Dallas, Texas, United States, 75228
United States, Washington
Recovery Centers of King County
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theresa Winhusen, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00628927     History of Changes
Other Study ID Numbers: NIDA-CTN-0031A, 5U10DA013732, U10DA013732
Study First Received: March 3, 2008
Results First Received: May 3, 2013
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014