Stimulant Dependence
Conditions
Brief summary
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.
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.
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroop Color-word Task | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barrett Impulsiveness Scale Version 11 (BIS-11) | 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). |
| Tail Length From the Comet Assay for Oxidative Damage | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Simulant Dependent Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031 | 183 |
| Normal Control Participants Normal Control participants recruited from the community | 30 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Equipment failure | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Problems performing blood draw | 6 | 0 |
Baseline characteristics
| Characteristic | Normal Control Participants | Simulant Dependent Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 183 Participants | 213 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 9.5 | 38.6 years STANDARD_DEVIATION 9.3 | 39.4 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 30 participants | 183 participants | 213 participants |
| Sex: Female, Male Female | 17 Participants | 125 Participants | 142 Participants |
| Sex: Female, Male Male | 13 Participants | 58 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 175 | 0 / 30 |
| serious Total, serious adverse events | 0 / 175 | 0 / 30 |
Outcome results
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.
Time frame: Single study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stimulant Dependent Completers | Stroop Color-word Task | 55.4 seconds | Standard Deviation 22.9 |
| Stimulant Dependent Treatment Non-Completers | Stroop Color-word Task | 50.5 seconds | Standard Deviation 21 |
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).
Time frame: Single study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stimulant Dependent Completers | Barrett Impulsiveness Scale Version 11 (BIS-11) | 66.7 units on a scale | Standard Deviation 9.3 |
| Stimulant Dependent Treatment Non-Completers | Barrett Impulsiveness Scale Version 11 (BIS-11) | 69.4 units on a scale | Standard Deviation 7.5 |
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.
Time frame: Single study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stimulant Dependent Completers | Tail Length From the Comet Assay for Oxidative Damage | 17.3 µm | Standard Deviation 10.1 |
| Stimulant Dependent Treatment Non-Completers | Tail Length From the Comet Assay for Oxidative Damage | 15.6 µm | Standard Deviation 8.5 |
| Normal Controls | Tail Length From the Comet Assay for Oxidative Damage | 16.5 µm | Standard Deviation 7.2 |