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

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT00628927
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 217
• Locations: 6
• Duration (Months): 24.9
• Patients Per Site: 36.2
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stimulant Dependence

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 217 participants
• 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

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

Locations

	Site	City	State	Country	Postal Code
1	Gateway Community Services	Jacksonville	Florida	United States	32211
2	Maryhaven	Columbus	Ohio	United States	43207
3	Willamette Family Treatment Services	'Eugene	Oregon	United States	97402
4	ChangePoint, Inc.	Portland	Oregon	United States	97292
5	Nexus Recovery Center	Dallas	Texas	United States	75228
6	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theresa Winhusen, Associate Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT00628927
• Other Study ID Numbers: NIDA-CTN-0031A; 5U10DA013732; U10DA013732
• First Posted: Mar 5, 2008
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

Study Results

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 Detail	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.

Arm/Group Title	Simulant Dependent Participants	Normal Control Participants
Arm/Group Description	Stimulant Dependent pts entering treatment who are also enrolled in CTN0031	Normal Control participants recruited from the community
Period Title: Overall Study
STARTED	183	30
COMPLETED	175	30
NOT COMPLETED	8	0

Baseline Characteristics

Arm/Group Title	Simulant Dependent Participants	Normal Control Participants	Total
Arm/Group Description	Stimulant Dependent pts entering treatment who are also enrolled in CTN0031	Normal Control participants recruited from the community	Total of all reporting groups
Overall Participants	183	30	213
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	183 100%	30 100%	213 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.6 (9.3)	44.5 (9.5)	39.4 (9.5)
Sex: Female, Male (Count of Participants)
Female	125 68.3%	17 56.7%	142 66.7%
Male	58 31.7%	13 43.3%	71 33.3%
Region of Enrollment (participants) [Number]
United States	183 100%	30 100%	213 100%

Outcome Measures

1. Primary Outcome

Title	Stroop Color-word Task
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stimulant Dependent Completers	Stimulant Dependent Treatment Non-Completers
Arm/Group Description	Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week	Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
Measure Participants	130	51
Mean (Standard Deviation) [seconds]	55.4 (22.9)	50.5 (21.0)

2. Secondary Outcome

Title	Barrett Impulsiveness Scale Version 11 (BIS-11)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stimulant Dependent Completers	Stimulant Dependent Treatment Non-Completers
Arm/Group Description	Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness	Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis. Data from 3 other participants was incomplete and therefore removed from the analysis.
Measure Participants	129	48
Mean (Standard Deviation) [units on a scale]	66.7 (9.3)	69.4 (7.5)

3. Secondary Outcome

Title	Tail Length From the Comet Assay for Oxidative Damage
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stimulant Dependent Completers	Stimulant Dependent Treatment Non-Completers	Normal Controls
Arm/Group Description	Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis	Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw 1 participant sample was insufficient for analysis	Normal controls recruited from the community.
Measure Participants	127	49	30
Mean (Standard Deviation) [µm]	17.3 (10.1)	15.6 (8.5)	16.5 (7.2)

Adverse Events

Arm/Group Title	Simulant Dependent Participants		Normal Control Participants
Arm/Group Description	Stimulant Dependent pts entering treatment who are also enrolled in CTN0031		Normal Control participants recruited from the community
All Cause Mortality
	Simulant Dependent Participants		Normal Control Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Simulant Dependent Participants		Normal Control Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/175 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Simulant Dependent Participants		Normal Control Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/175 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.