Trial Outcomes & Findings for Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking (NCT NCT02224391)
NCT ID: NCT02224391
Last Updated: 2023-03-07
Results Overview
Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
311 participants
Primary outcome timeframe
Up to 8 weeks post-training
Results posted on
2023-03-07
Participant Flow
246 participants were randomized
Participant milestones
| Measure |
Arm I: Attention Bias Modification (ABM) Training
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
122
|
|
Overall Study
COMPLETED
|
92
|
98
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
| Measure |
Arm I: Attention Bias Modification (ABM) Training
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
19
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking
Baseline characteristics by cohort
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.27 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
45.28 years
STANDARD_DEVIATION 11.65 • n=7 Participants
|
46.28 years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 participants
n=5 Participants
|
122 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Years of education
|
13.35 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
13.72 years
STANDARD_DEVIATION 2 • n=7 Participants
|
13.53 years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
|
Number of Participants Employed
|
83 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Fagerström Test for Nicotine Dependence (FTND) total score
|
4.82 score on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
4.96 score on a scale
STANDARD_DEVIATION 2.11 • n=7 Participants
|
4.89 score on a scale
STANDARD_DEVIATION 2.12 • n=5 Participants
|
|
Cigarettes per day
|
18.14 cigarettes per day
STANDARD_DEVIATION 8.87 • n=5 Participants
|
18.48 cigarettes per day
STANDARD_DEVIATION 9.27 • n=7 Participants
|
18.31 cigarettes per day
STANDARD_DEVIATION 9.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks post-trainingModified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Modified Dot-probe Task
Baseline
|
5.49 milliseconds
Standard Error 0.99
|
7.49 milliseconds
Standard Error 1
|
|
Modified Dot-probe Task
1-day post-training
|
2.42 milliseconds
Standard Error 1.04
|
9.85 milliseconds
Standard Error 1.03
|
|
Modified Dot-probe Task
8-weeks post-training
|
4.94 milliseconds
Standard Error 1.19
|
9.48 milliseconds
Standard Error 1.14
|
PRIMARY outcome
Timeframe: Up to 8 weeks post-trainingThe Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Smoking Stroop Task
Baseline
|
-6.57 milisecond
Standard Error 4.11
|
4.94 milisecond
Standard Error 4.15
|
|
Smoking Stroop Task
1-day post-training
|
-2.38 milisecond
Standard Error 4.31
|
3.73 milisecond
Standard Error 4.29
|
|
Smoking Stroop Task
8-weeks post-training
|
-4.59 milisecond
Standard Error 4.94
|
10.97 milisecond
Standard Error 4.7
|
SECONDARY outcome
Timeframe: Up to 8 weeks post-trainingMean number of cigarettes per day smoked for the seven days preceding each time point.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Cigarette Per Day (CPD)
Baseline
|
18.1 number of cigerettes
Standard Error 0.8
|
18.45 number of cigerettes
Standard Error 0.81
|
|
Cigarette Per Day (CPD)
1-day post-training
|
14.94 number of cigerettes
Standard Error 0.82
|
14.78 number of cigerettes
Standard Error 0.83
|
|
Cigarette Per Day (CPD)
8-weeks post-training
|
8.29 number of cigerettes
Standard Error 0.9
|
7.52 number of cigerettes
Standard Error 0.87
|
SECONDARY outcome
Timeframe: Up to 8 weeks post-trainingMean expired carbon monoxide, in ppm (parts per million), at each time point.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Expired Carbon Monoxide (CO)
Baseline
|
22.41 Parts Per Million
Standard Error 1.1
|
22.27 Parts Per Million
Standard Error 1.11
|
|
Expired Carbon Monoxide (CO)
1-day post-training
|
22.28 Parts Per Million
Standard Error 1.13
|
22.95 Parts Per Million
Standard Error 1.13
|
|
Expired Carbon Monoxide (CO)
8-day post-training
|
12.54 Parts Per Million
Standard Error 1.24
|
12.99 Parts Per Million
Standard Error 1.19
|
SECONDARY outcome
Timeframe: Up to 8 weeks post-trainingMean urinary cotinine, measured in ng/mL, at each time point.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Urinary Cotinine
Baseline
|
7.11 ng/mL
Standard Error .99
|
7.12 ng/mL
Standard Error .09
|
|
Urinary Cotinine
1-Day post-training
|
6.91 ng/mL
Standard Error .09
|
6.99 ng/mL
Standard Error .09
|
|
Urinary Cotinine
8-Day post-training
|
6.16 ng/mL
Standard Error .12
|
6.61 ng/mL
Standard Error .12
|
SECONDARY outcome
Timeframe: Up to 8 weeks post-trainingThe Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Fagerström Test for Nicotine Dependence (FTND)
Baseline
|
4.84 score on a scale
Standard Error 0.19
|
4.96 score on a scale
Standard Error 0.19
|
|
Fagerström Test for Nicotine Dependence (FTND)
1-day post-training
|
4.34 score on a scale
Standard Error 0.2
|
4.05 score on a scale
Standard Error 0.2
|
|
Fagerström Test for Nicotine Dependence (FTND)
8-weeks post-training
|
2.93 score on a scale
Standard Error 0.21
|
2.65 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Up to 8 weeks post-trainingMean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.
Outcome measures
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 Participants
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 Participants
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
Baseline
|
9.9 score on a scale
Standard Error 0.29
|
9.76 score on a scale
Standard Error 0.29
|
|
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
1-day post-training
|
8.36 score on a scale
Standard Error 0.3
|
8.52 score on a scale
Standard Error 0.3
|
|
Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
8-weeks post-training
|
6.92 score on a scale
Standard Error 0.34
|
6.73 score on a scale
Standard Error 0.32
|
Adverse Events
Arm I: Attention Bias Modification (ABM) Training
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
Arm II: Sham Training
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 participants at risk
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 participants at risk
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Insomnia
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
Other adverse events
| Measure |
Arm I: Attention Bias Modification (ABM) Training
n=124 participants at risk
Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
Arm II: Sham Training
n=122 participants at risk
Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
|
|---|---|---|
|
Nervous system disorders
Abnormal dreams
|
15.3%
19/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
15.6%
19/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Anxiety
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Nervous system disorders
Concentration impairment
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
2/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Depression
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
1.6%
2/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Nervous system disorders
Dizziness
|
4.0%
5/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
2.5%
3/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
General disorders
Fatigue
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Flatulence
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Nervous system disorders
Headache
|
4.0%
5/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
4.1%
5/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Insomnia
|
12.1%
15/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
8.2%
10/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Infections and infestations
Mucosal infection
|
1.6%
2/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
5/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
4.9%
6/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.00%
0/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Cardiac disorders
Palpitations
|
0.81%
1/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.8%
32/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
34.4%
42/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/124 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
0.82%
1/122 • 12 weeks
Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.
|
Additional Information
Dr. Jason Robinson, PHD- Associate Professor, Behavioral Science
UT MD Anderson Cancer Center
Phone: (713) 792-0919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place