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

1. december 2015 opdateret af: Theresa Winhusen, University of Cincinnati

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

Studieoversigt

Status

Afsluttet

Betingelser

Stimulerende afhængighed

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

217

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Florida
  - Jacksonville, Florida, Forenede Stater, 32211
    - Gateway Community Services
- Ohio
  - Columbus, Ohio, Forenede Stater, 43207
    - Maryhaven
- Oregon
  - 'Eugene, Oregon, Forenede Stater, 97402
    - Willamette Family Treatment Services
  - Portland, Oregon, Forenede Stater, 97292
    - ChangePoint, Inc.
- Texas
  - Dallas, Texas, Forenede Stater, 75228
    - Nexus Recovery Center
- Washington
  - Seattle, Washington, Forenede Stater, 98122
    - Recovery Centers of King County

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Case-Control
Tidsperspektiver: Tværsnit

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Stroop Color-word Task Tidsramme: 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.	Single study visit

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Barrett Impulsiveness Scale Version 11 (BIS-11) Tidsramme: 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).	Single study visit
Tail Length From the Comet Assay for Oxidative Damage Tidsramme: 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.	Single study visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cincinnati

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

Ledende efterforsker: Theresa Winhusen, Ph.D., University of Cincinnati

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2008

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. marts 2010

Datoer for studieregistrering

Først indsendt

3. marts 2008

Først indsendt, der opfyldte QC-kriterier