Tobacco Use Disorder, Nicotine Addiction
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Point-prevalence Abstinence at End of Treatment | End 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
| Measure | Time frame | Description |
|---|---|---|
| Point-prevalence Abstinence at 6-month Follow-up | 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. |
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 10 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | Control Training | Total | Cognitive Training |
|---|---|---|---|
| Age, Continuous | 43.39 years STANDARD_DEVIATION 12.38 | 43.28 years STANDARD_DEVIATION 12.48 | 43.18 years STANDARD_DEVIATION 12.62 |
| Cigarettes Per Day | 15.73 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 Participants | 6 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 207 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fagerström Test for Nicotine Dependence Score | 4.65 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 Participants | 107 Participants | 53 Participants |
| Gender Male | 51 Participants | 106 Participants | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 80 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 54 Participants | 115 Participants | 61 Participants |
| Region of Enrollment United States | 105 participants | 213 participants | 108 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 108 | 54 / 105 |
| serious Total, serious adverse events | 6 / 108 | 3 / 105 |
Outcome results
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive Training | Point-prevalence Abstinence at End of Treatment | 38 Percentage of participants |
| Control Training | Point-prevalence Abstinence at End of Treatment | 43 Percentage of participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Cognitive Performance (Attention) | -0.27 Change in number of commission errors | Standard Deviation 1.3 |
| Control Training | Cognitive Performance (Attention) | 0.54 Change in number of commission errors | Standard Deviation 1.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Cognitive Performance (Response Inhibition) | -0.84 Change in number of commission errors | Standard Deviation 2.5 |
| Control Training | Cognitive Performance (Response Inhibition) | -0.49 Change in number of commission errors | Standard Deviation 2.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Cognitive Performance (Working Memory) | 0.22 Change in maximum recall span | Standard Deviation 1.2 |
| Control Training | Cognitive Performance (Working Memory) | 0.03 Change in maximum recall span | Standard Deviation 1.1 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive Training | Point-prevalence Abstinence at 6-month Follow-up | 15 Percentage of participants |
| Control Training | Point-prevalence Abstinence at 6-month Follow-up | 25 Percentage of participants |