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

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 Abuse or 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:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Cocaine hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

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
Non METH and/or cocaine dependent group

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:

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.

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)

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

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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Theresa Winhusen, Ph.D.

University of Cincinnati

More Information

Publications:

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. 2012 Jul 6. [Epub ahead of print]

Responsible Party:	Theresa Winhusen, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00628927 History of Changes
Other Study ID Numbers:	NIDA-CTN-0031A, 5U10DA013732, U10 DA13732
Study First Received:	March 3, 2008
Last Updated:	July 13, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013