- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00628927
An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Florida
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Jacksonville, Florida, Stati Uniti, 32211
- Gateway Community Services
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Ohio
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Columbus, Ohio, Stati Uniti, 43207
- Maryhaven
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Oregon
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'Eugene, Oregon, Stati Uniti, 97402
- Willamette Family Treatment Services
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Portland, Oregon, Stati Uniti, 97292
- ChangePoint, Inc.
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Texas
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Dallas, Texas, Stati Uniti, 75228
- Nexus Recovery Center
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Washington
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Seattle, Washington, Stati Uniti, 98122
- Recovery Centers of King County
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
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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.
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Non METH and/or cocaine dependent group
The Non METH and/or cocaine dependent group participants are normal controls recruited from the community.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Stroop Color-word Task
Lasso di tempo: Single study visit
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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.
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Single study visit
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Barrett Impulsiveness Scale Version 11 (BIS-11)
Lasso di tempo: Single study visit
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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).
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Single study visit
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Tail Length From the Comet Assay for Oxidative Damage
Lasso di tempo: Single study visit
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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.
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Single study visit
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Theresa Winhusen, Ph.D., University of Cincinnati
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
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Completamento primario (Effettivo)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NIDA-CTN-0031A
- U10DA013732 (Sovvenzione/contratto NIH degli Stati Uniti)
- 5U10DA013732 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .