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Cognitive Training for Nicotine Dependence

Cognitive Training for Nicotine Dependence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01252966
Enrollment
213
Registered
2010-12-03
Start date
2011-03-31
Completion date
2015-09-30
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder, Nicotine Addiction

Keywords

Tobacco, Smoking, Cognition, Behavioral Training, Relapse

Brief summary

This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation. All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.

Interventions

BEHAVIORALCognitive Training

The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.

The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inclusion: 1. Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months 2. Plan to live in the area for at least the next 8 months 3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form 4. Able to communicate fluently in English (speaking, writing, and reading) 5. Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection 6. Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit

Design outcomes

Primary

MeasureTime frameDescription
Point-prevalence Abstinence at End of TreatmentEnd of treatment (Week 12)Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO \<8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.

Secondary

MeasureTime frameDescription
Point-prevalence Abstinence at 6-month Follow-up6 month follow-upDaily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO \<8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.
Cognitive Performance (Working Memory)Baseline and Week 12 (EOT)Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.
Cognitive Performance (Response Inhibition)Baseline and Week 12 (EOT)Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change.
Cognitive Performance (Attention)Baseline and Week 12 (EOT)Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.

Countries

United States

Participant flow

Recruitment details

Recruitment for this clinical trial began in March 2011. Study accrual was completed in September 2015, with a final sample of N=213 in the intention-to-treat (ITT) analysis.

Pre-assignment details

Five hundred and fifty-seven participants provided consent and 213 were randomized. Reasons for exclusion from randomization included no home computer or internet access and failure to meet final eligibility criteria at the Intake Visit.

Participants by arm

ArmCount
Cognitive Training
The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
108
Control Training
The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
105
Total213

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1610
Overall StudyWithdrawal by Subject73

Baseline characteristics

CharacteristicControl TrainingTotalCognitive Training
Age, Continuous43.39 years
STANDARD_DEVIATION 12.38
43.28 years
STANDARD_DEVIATION 12.48
43.18 years
STANDARD_DEVIATION 12.62
Cigarettes Per Day15.73 cigarettes smoked per day
STANDARD_DEVIATION 5.23
16.08 cigarettes smoked per day
STANDARD_DEVIATION 5.7
16.42 cigarettes smoked per day
STANDARD_DEVIATION 6.14
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants6 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
100 Participants207 Participants107 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Fagerström Test for Nicotine Dependence Score4.65 units on a scale
STANDARD_DEVIATION 1.74
4.74 units on a scale
STANDARD_DEVIATION 1.94
4.82 units on a scale
STANDARD_DEVIATION 2.11
Gender
Female
54 Participants107 Participants53 Participants
Gender
Male
51 Participants106 Participants55 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants6 Participants4 Participants
Race (NIH/OMB)
Black or African American
42 Participants80 Participants38 Participants
Race (NIH/OMB)
More than one race
4 Participants7 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants4 Participants1 Participants
Race (NIH/OMB)
White
54 Participants115 Participants61 Participants
Region of Enrollment
United States
105 participants213 participants108 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
42 / 10854 / 105
serious
Total, serious adverse events
6 / 1083 / 105

Outcome results

Primary

Point-prevalence Abstinence at End of Treatment

Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO \<8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.

Time frame: End of treatment (Week 12)

ArmMeasureValue (NUMBER)
Cognitive TrainingPoint-prevalence Abstinence at End of Treatment38 Percentage of participants
Control TrainingPoint-prevalence Abstinence at End of Treatment43 Percentage of participants
Comparison: Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).p-value: 0.1495% CI: [0.42, 1.13]Regression, Logistic
Secondary

Cognitive Performance (Attention)

Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.

Time frame: Baseline and Week 12 (EOT)

Population: Participants with performance \>3SD from the mean at Baseline were excluded as outliers.

ArmMeasureValue (MEAN)Dispersion
Cognitive TrainingCognitive Performance (Attention)-0.27 Change in number of commission errorsStandard Deviation 1.3
Control TrainingCognitive Performance (Attention)0.54 Change in number of commission errorsStandard Deviation 1.6
Comparison: Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.p-value: 0.033Regression, Linear
Secondary

Cognitive Performance (Response Inhibition)

Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change.

Time frame: Baseline and Week 12 (EOT)

Population: Participants with performance \>3SD from the mean at baseline were excluded as outliers.

ArmMeasureValue (MEAN)Dispersion
Cognitive TrainingCognitive Performance (Response Inhibition)-0.84 Change in number of commission errorsStandard Deviation 2.5
Control TrainingCognitive Performance (Response Inhibition)-0.49 Change in number of commission errorsStandard Deviation 2.5
Comparison: Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.p-value: 0.3Regression, Linear
Secondary

Cognitive Performance (Working Memory)

Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.

Time frame: Baseline and Week 12 (EOT)

Population: Participants with performance \>3SD from the mean at baseline were excluded as outliers.

ArmMeasureValue (MEAN)Dispersion
Cognitive TrainingCognitive Performance (Working Memory)0.22 Change in maximum recall spanStandard Deviation 1.2
Control TrainingCognitive Performance (Working Memory)0.03 Change in maximum recall spanStandard Deviation 1.1
Comparison: Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.p-value: 0.3Regression, Linear
Secondary

Point-prevalence Abstinence at 6-month Follow-up

Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO \<8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.

Time frame: 6 month follow-up

ArmMeasureValue (NUMBER)
Cognitive TrainingPoint-prevalence Abstinence at 6-month Follow-up15 Percentage of participants
Control TrainingPoint-prevalence Abstinence at 6-month Follow-up25 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026