Trial Outcomes & Findings for An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers. (NCT NCT00628927)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

217 participants

Primary outcome timeframe

Single study visit

Results posted on

2015-12-30

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Simulant Dependent Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031	Normal Control Participants Normal Control participants recruited from the community
Overall Study STARTED	183	30
Overall Study COMPLETED	175	30
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Simulant Dependent Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031	Normal Control Participants Normal Control participants recruited from the community
Overall Study Problems performing blood draw	6	0
Overall Study Lost to Follow-up	1	0
Overall Study Equipment failure	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulant Dependent Participants n=183 Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031	Normal Control Participants n=30 Participants Normal Control participants recruited from the community	Total n=213 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	183 Participants n=5 Participants	30 Participants n=7 Participants	213 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 9.3 • n=5 Participants	44.5 years STANDARD_DEVIATION 9.5 • n=7 Participants	39.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	17 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	13 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants	30 participants n=7 Participants	213 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stimulant Dependent Completers n=130 Participants 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	Stimulant Dependent Treatment Non-Completers n=51 Participants 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.	Normal Controls Normal controls recruited from the community.
Stroop Color-word Task	55.4 seconds Standard Deviation 22.9	50.5 seconds Standard Deviation 21.0	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Stimulant Dependent Completers n=129 Participants 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	Stimulant Dependent Treatment Non-Completers n=48 Participants 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.	Normal Controls Normal controls recruited from the community.
Barrett Impulsiveness Scale Version 11 (BIS-11)	66.7 units on a scale Standard Deviation 9.3	69.4 units on a scale Standard Deviation 7.5	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stimulant Dependent Completers n=127 Participants 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	Stimulant Dependent Treatment Non-Completers n=49 Participants 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.	Normal Controls n=30 Participants Normal controls recruited from the community.
Tail Length From the Comet Assay for Oxidative Damage	17.3 µm Standard Deviation 10.1	15.6 µm Standard Deviation 8.5	16.5 µm Standard Deviation 7.2

Adverse Events

Simulant Dependent Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Control Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Theresa Winhusen

University of Cincinnati

Phone: 513-487-7800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place