Trial Outcomes & Findings for Cognitive Training for Nicotine Dependence (NCT NCT01252966)
NCT ID: NCT01252966
Last Updated: 2017-01-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
End of treatment (Week 12)
Results posted on
2017-01-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
105
|
|
Overall Study
COMPLETED
|
85
|
92
|
|
Overall Study
NOT COMPLETED
|
23
|
13
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
10
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
Baseline Characteristics
Cognitive Training for Nicotine Dependence
Baseline characteristics by cohort
| Measure |
Cognitive Training
n=108 Participants
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.
|
Control Training
n=105 Participants
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.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.18 years
STANDARD_DEVIATION 12.62 • n=93 Participants
|
43.39 years
STANDARD_DEVIATION 12.38 • n=4 Participants
|
43.28 years
STANDARD_DEVIATION 12.48 • n=27 Participants
|
|
Gender
Female
|
53 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Gender
Male
|
55 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
207 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=93 Participants
|
105 participants
n=4 Participants
|
213 participants
n=27 Participants
|
|
Cigarettes Per Day
|
16.42 cigarettes smoked per day
STANDARD_DEVIATION 6.14 • n=93 Participants
|
15.73 cigarettes smoked per day
STANDARD_DEVIATION 5.23 • n=4 Participants
|
16.08 cigarettes smoked per day
STANDARD_DEVIATION 5.70 • n=27 Participants
|
|
Fagerström Test for Nicotine Dependence Score
|
4.82 units on a scale
STANDARD_DEVIATION 2.11 • n=93 Participants
|
4.65 units on a scale
STANDARD_DEVIATION 1.74 • n=4 Participants
|
4.74 units on a scale
STANDARD_DEVIATION 1.94 • n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cognitive Training
n=108 Participants
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.
|
Control Training
n=105 Participants
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.
|
|---|---|---|
|
Point-prevalence Abstinence at End of Treatment
|
38 Percentage of participants
|
43 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
Cognitive Training
n=108 Participants
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.
|
Control Training
n=105 Participants
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.
|
|---|---|---|
|
Point-prevalence Abstinence at 6-month Follow-up
|
15 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (EOT)Population: Participants with performance \>3SD from the mean at baseline were excluded as outliers.
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.
Outcome measures
| Measure |
Cognitive Training
n=82 Participants
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.
|
Control Training
n=92 Participants
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.
|
|---|---|---|
|
Cognitive Performance (Working Memory)
|
0.22 Change in maximum recall span
Standard Deviation 1.2
|
0.03 Change in maximum recall span
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (EOT)Population: Participants with performance \>3SD from the mean at baseline were excluded as outliers.
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.
Outcome measures
| Measure |
Cognitive Training
n=82 Participants
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.
|
Control Training
n=92 Participants
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.
|
|---|---|---|
|
Cognitive Performance (Response Inhibition)
|
-0.84 Change in number of commission errors
Standard Deviation 2.5
|
-0.49 Change in number of commission errors
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (EOT)Population: Participants with performance \>3SD from the mean at Baseline were excluded as outliers.
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.
Outcome measures
| Measure |
Cognitive Training
n=82 Participants
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.
|
Control Training
n=92 Participants
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.
|
|---|---|---|
|
Cognitive Performance (Attention)
|
-0.27 Change in number of commission errors
Standard Deviation 1.3
|
0.54 Change in number of commission errors
Standard Deviation 1.6
|
Adverse Events
Cognitive Training
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Control Training
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Training
n=108 participants at risk
|
Control Training
n=105 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Squamous Cell Carcinoma
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Infections and infestations
Infection
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
General disorders
Pancreatitis
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Surgical and medical procedures
Emergency Procedure
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Gastrointestinal disorders
Bowel Blockage
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Respiratory, thoracic and mediastinal disorders
Collapsed Lung
|
0.93%
1/108 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.00%
0/105 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.00%
0/108 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
0.95%
1/105 • Number of events 1 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Surgical and medical procedures
Surgery (Gastric Bypass)
|
0.00%
0/108 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
1.9%
2/105 • Number of events 2 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
Other adverse events
| Measure |
Cognitive Training
n=108 participants at risk
|
Control Training
n=105 participants at risk
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.3%
10/108 • Number of events 11 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
11.4%
12/105 • Number of events 12 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Gastrointestinal disorders
Nausea
|
5.6%
6/108 • Number of events 6 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
5.7%
6/105 • Number of events 6 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Psychiatric disorders
Insomnia
|
20.4%
22/108 • Number of events 35 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
35.2%
37/105 • Number of events 59 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
7.4%
8/108 • Number of events 11 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
12.4%
13/105 • Number of events 13 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.6%
5/108 • Number of events 9 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
6.7%
7/105 • Number of events 7 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Psychiatric disorders
Disturbing Dreams
|
9.3%
10/108 • Number of events 10 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
11.4%
12/105 • Number of events 13 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.7%
4/108 • Number of events 5 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
6.7%
7/105 • Number of events 7 • AE and SAE data were collected from enrollment through follow up (~31 weeks).
Participants (PPTs) completed an anticipated side effects questionnaire (transdermal nicotine) at Pre-Quit (baseline measure) and at every subsequent in-person visit during the treatment period (systematic assessment). AE and SAE information was collected via spontaneous report from enrollment through follow up as a non-systematic assessment (n=213).
|
Additional Information
Benjamin Albelda (Project Manager)
University of Pennsylvania (Perelman School of Medicine)
Phone: 2157467173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place