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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10DA013732 | U.S. NIH Grant/Contract | View source | |
| U10DA013732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Stroop Color-word Task | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Barrett Impulsiveness Scale Version 11 (BIS-11) | 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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Inclusion Criteria (METH and/or Cocaine Dependent Group):
Exclusion Criteria (METH and/or Cocaine Dependent Group):
Inclusion Criteria (Non-METH and/or Cocaine Dependent Group):
Exclusion Criteria (Non-METH and/or Cocaine Dependent Group):
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Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Winhusen, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Community Services | Jacksonville | Florida | 32211 | United States | ||
| Maryhaven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22771145 | Result | 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. | |
| 23808868 | Derived | 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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6 stimulant abusers met at least one exclusion criterion, 3 for a history of stroke and 3 for a history of seizures. 2 of those 6 were incorrectly enrolled into the study. The most common exclusion criteria met by the normal control screeners was having a DSM-IV substance use diagnosis and positive urine toxicology screen.
As an ancillary study to CTN-0031, six of the nine sites participating in CTN-0031 were chosen to participate in the present study. At the participating sites, participants who were randomized into CTN-0031 were eligible to be screened for the present study. Normal controls were recruited via advertising from one study site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Simulant Dependent Participants | Stimulant Dependent pts entering treatment who are also enrolled in CTN0031 |
| FG001 | Normal Control Participants | Normal Control participants recruited from the community |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Blood sample for the oxidative stress/damage analysis
| Single study visit |
| Tail Length From the Comet Assay for Oxidative Damage | 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 |
| Columbus |
| Ohio |
| 43207 |
| United States |
| Willamette Family Treatment Services | Eugene | Oregon | 97402 | United States |
| ChangePoint, Inc. | Portland | Oregon | 97292 | United States |
| Nexus Recovery Center | Dallas | Texas | 75228 | United States |
| Recovery Centers of King County | Seattle | Washington | 98122 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Stimulant dependent participants were starting treatment, and participating in the CTN0031 study. Normal controls were recruited from the community.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simulant Dependent Participants | Stimulant Dependent pts entering treatment who are also enrolled in CTN0031 |
| BG001 | Normal Control Participants | Normal Control participants recruited from the community |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stroop Color-word Task | 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. | Posted | Mean | Standard Deviation | seconds | Single study visit |
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| Secondary | Barrett Impulsiveness Scale Version 11 (BIS-11) | 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). | Posted | Mean | Standard Deviation | units on a scale | Single study visit |
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| Secondary | Tail Length From the Comet Assay for Oxidative Damage | 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. | Posted | Mean | Standard Deviation | µm | Single study visit |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simulant Dependent Participants | Stimulant Dependent pts entering treatment who are also enrolled in CTN0031 | 0 | 175 | 0 | 175 | ||
| EG001 | Normal Control Participants | Normal Control participants recruited from the community | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theresa Winhusen | University of Cincinnati | 513-487-7800 | winhusen@carc.uc.edu |
| >=65 years |
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| Male |
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