Trial Outcomes & Findings for UW Withdraw From Tobacco Study (NCT NCT04969198)
NCT ID: NCT04969198
Last Updated: 2025-05-08
Results Overview
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
232 participants
Primary outcome timeframe
pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Overall Study
STARTED
|
232
|
|
Overall Study
Number Participants for 2 Weeks Pre-quit Timepoint Analysis
|
218
|
|
Overall Study
Number Participants for 1 Week Pre-quit Timepoint Analysis
|
208
|
|
Overall Study
Number Participants for 1-3 Days Pre-quit Timepoint Analysis
|
199
|
|
Overall Study
Number Participants for 1-2 Days Post-quit Timepoint Analysis
|
198
|
|
Overall Study
Number Participants for 1 Week Post-quit Timepoint Analysis
|
195
|
|
Overall Study
Number Participants for 2 Weeks Post-quit Timepoint Analysis
|
186
|
|
Overall Study
Number Participants for 9 Weeks Post-quit Timepoint Analysis
|
176
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Overall Study
Withdrawal by Subject
|
20
|
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Overall Study
Withdrawn by PI for Participant Non-Compliance
|
16
|
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Overall Study
Lost to Follow-up
|
20
|
Baseline Characteristics
UW Withdraw From Tobacco Study
Baseline characteristics by cohort
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
184 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
116 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
112 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
221 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
2 weeks pre-quit
|
2.64 score on a scale
Standard Deviation 1.13
|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
1 week pre-quit
|
2.36 score on a scale
Standard Deviation 1.02
|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
1-3 days pre-quit
|
2.29 score on a scale
Standard Deviation 1.03
|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
1-2 days post-quit
|
2.69 score on a scale
Standard Deviation 1.57
|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
1 week post-quit
|
2.73 score on a scale
Standard Deviation 1.29
|
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Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
2 weeks post-quit
|
2.32 score on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Brief Version. WSWS-2 consists of 6 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Higher scores indicate more severe withdrawal symptoms.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
2 weeks pre-quit
|
2.69 score on a scale
Standard Deviation 1.27
|
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
1 week pre-quit
|
2.38 score on a scale
Standard Deviation 1.15
|
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
1-3 days pre-quit
|
2.33 score on a scale
Standard Deviation 1.15
|
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
1-2 days post-quit
|
2.74 score on a scale
Standard Deviation 1.25
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
1 week post-quit
|
2.72 score on a scale
Standard Deviation 1.21
|
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Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
2 weeks post-quit
|
2.29 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
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Change in WSWS2-L Subscale Score : Craving
2 weeks pre-quit
|
4.55 score on a scale
Standard Deviation 1.75
|
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Change in WSWS2-L Subscale Score : Craving
1 week pre-quit
|
4.12 score on a scale
Standard Deviation 1.75
|
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Change in WSWS2-L Subscale Score : Craving
1-3 days pre-quit
|
3.98 score on a scale
Standard Deviation 1.75
|
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Change in WSWS2-L Subscale Score : Craving
1-2 days post-quit
|
4.86 score on a scale
Standard Deviation 1.76
|
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Change in WSWS2-L Subscale Score : Craving
1 week post-quit
|
4.47 score on a scale
Standard Deviation 1.8
|
|
Change in WSWS2-L Subscale Score : Craving
2 weeks post-quit
|
3.3 score on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
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|---|---|
|
Change in WSWS2-L Subscale Score : Negative Affect
2 weeks pre-quit
|
2.13 score on a scale
Standard Deviation 1.41
|
|
Change in WSWS2-L Subscale Score : Negative Affect
1 week pre-quit
|
1.95 score on a scale
Standard Deviation 1.33
|
|
Change in WSWS2-L Subscale Score : Negative Affect
1-3 days pre-quit
|
1.92 score on a scale
Standard Deviation 1.21
|
|
Change in WSWS2-L Subscale Score : Negative Affect
1-2 days post-quit
|
2.35 score on a scale
Standard Deviation 1.48
|
|
Change in WSWS2-L Subscale Score : Negative Affect
1 week post-quit
|
2.48 score on a scale
Standard Deviation 1.6
|
|
Change in WSWS2-L Subscale Score : Negative Affect
2 weeks post-quit
|
2.06 score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in WSWS2-L Subscale Score : Concentration
2 weeks pre-quit
|
1.94 score on a scale
Standard Deviation 1.28
|
|
Change in WSWS2-L Subscale Score : Concentration
1 week pre-quit
|
1.73 score on a scale
Standard Deviation 1.11
|
|
Change in WSWS2-L Subscale Score : Concentration
1-3 days pre-quit
|
1.74 score on a scale
Standard Deviation 1.28
|
|
Change in WSWS2-L Subscale Score : Concentration
1-2 days post-quit
|
2.04 score on a scale
Standard Deviation 1.43
|
|
Change in WSWS2-L Subscale Score : Concentration
1 week post-quit
|
2.18 score on a scale
Standard Deviation 1.56
|
|
Change in WSWS2-L Subscale Score : Concentration
2 weeks post-quit
|
1.86 score on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in WSWS2-L Subscale Score : Sleep Problems
2 weeks pre-quit
|
2.73 score on a scale
Standard Deviation 1.63
|
|
Change in WSWS2-L Subscale Score : Sleep Problems
1 week pre-quit
|
2.35 score on a scale
Standard Deviation 1.44
|
|
Change in WSWS2-L Subscale Score : Sleep Problems
1-3 days pre-quit
|
2.24 score on a scale
Standard Deviation 1.47
|
|
Change in WSWS2-L Subscale Score : Sleep Problems
1-2 days post-quit
|
2.37 score on a scale
Standard Deviation 1.49
|
|
Change in WSWS2-L Subscale Score : Sleep Problems
1 week post-quit
|
2.55 score on a scale
Standard Deviation 1.58
|
|
Change in WSWS2-L Subscale Score : Sleep Problems
2 weeks post-quit
|
2.37 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in WSWS2-L Subscale Score: Hunger
2 weeks pre-quit
|
2.39 score on a scale
Standard Deviation 1.46
|
|
Change in WSWS2-L Subscale Score: Hunger
1 week pre-quit
|
2.19 score on a scale
Standard Deviation 1.38
|
|
Change in WSWS2-L Subscale Score: Hunger
1-3 days pre-quit
|
2.06 score on a scale
Standard Deviation 1.23
|
|
Change in WSWS2-L Subscale Score: Hunger
1-2 days post-quit
|
2.34 score on a scale
Standard Deviation 1.4
|
|
Change in WSWS2-L Subscale Score: Hunger
1 week post-quit
|
2.44 score on a scale
Standard Deviation 1.42
|
|
Change in WSWS2-L Subscale Score: Hunger
2 weeks post-quit
|
2.39 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in WSWS2-L Subscale Score : Restlessness
2 weeks pre-quit
|
2.13 score on a scale
Standard Deviation 1.41
|
|
Change in WSWS2-L Subscale Score : Restlessness
1 week pre-quit
|
1.95 score on a scale
Standard Deviation 1.33
|
|
Change in WSWS2-L Subscale Score : Restlessness
1-3 days pre-quit
|
1.92 score on a scale
Standard Deviation 1.21
|
|
Change in WSWS2-L Subscale Score : Restlessness
1-2 days post-quit
|
2.35 score on a scale
Standard Deviation 1.48
|
|
Change in WSWS2-L Subscale Score : Restlessness
1 week post-quit
|
2.48 score on a scale
Standard Deviation 1.6
|
|
Change in WSWS2-L Subscale Score : Restlessness
2 weeks post-quit
|
2.06 score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: 9 weeks after quit datePopulation: Investigators use 'intent-to-treat' analysis for this outcome measure so people who are lost to follow up are counted as still smoking (not abstinent).
Biochemically confirmed self-reported total abstinence from any cigarette use (even a single puff) for the seven days preceding the target follow up day, confirmed with carbon monoxide reading of less than or equal to 5 ppm.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent
|
46 Participants
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Self-reported withdrawal symptom severity in the last 24 hours using the Minnesota Tobacco Withdrawal Scale (MTWS). MTWS consists of 17 items. Mean score from 0 to 4 is reported. Higher scores indicate more severe withdrawal symptoms.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
2 weeks pre-quit
|
0.965 score on a scale
Standard Deviation 0.89
|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
1 week pre-quit
|
0.855 score on a scale
Standard Deviation 0.83
|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
1-3 days pre-quit
|
0.837 score on a scale
Standard Deviation 0.83
|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
1-2 days post-quit
|
1.16 score on a scale
Standard Deviation 0.93
|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
1 week post-quit
|
1.2 score on a scale
Standard Deviation 0.95
|
|
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
2 weeks post-quit
|
1.00 score on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)Population: Not all participants contributed data for each time point.
Exploratory subscale of the WSWS2-L, self-reported withdrawal symptom severity subscales (negative affect, craving, hunger, sleep, restlessness, concentration) in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2 Long Version. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours.
Outcome measures
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 Participants
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Change in WSWS2-L Subscale Score: Anhedonia
1 week pre-quit
|
1.75 score on a scale
Standard Deviation 1.41
|
|
Change in WSWS2-L Subscale Score: Anhedonia
2 weeks pre-quit
|
1.93 score on a scale
Standard Deviation 1.46
|
|
Change in WSWS2-L Subscale Score: Anhedonia
1-3 days pre-quit
|
1.65 score on a scale
Standard Deviation 1.37
|
|
Change in WSWS2-L Subscale Score: Anhedonia
1-2 days post-quit
|
1.91 score on a scale
Standard Deviation 1.5
|
|
Change in WSWS2-L Subscale Score: Anhedonia
1 week post-quit
|
2.03 score on a scale
Standard Deviation 1.49
|
|
Change in WSWS2-L Subscale Score: Anhedonia
2 weeks post-quit
|
1.79 score on a scale
Standard Deviation 1.22
|
Adverse Events
Nicotine Patch + Nicotine Mini Lozenge
Serious events: 8 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 participants at risk
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Renal and urinary disorders
Kidney Stones
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Cardiac disorders
Heart Failure
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Infections and infestations
Campylobacter Colitis
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Cardiac disorders
Atrial fibrillation and heart failure
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Volvulus
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
Other adverse events
| Measure |
Nicotine Patch + Nicotine Mini Lozenge
n=232 participants at risk
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge): Nicotine patch and mini-lozenge dosing will be based off the 2008 Public Health Services (PHS) Clinical Practice Guideline and package insert with adjustments to account for the delayed start 1-week post-TQD. All participants will receive 2mg mini-lozenge due to the superior palatability of the 2mg lozenges. Participants are encouraged to use at least 5 mini-lozenges per day for the full 8 weeks. Participants who report any smoking or nicotine use (e.g., even a cigarette puff, e-cigarette use) in the 3 days before C-NRT distribution will receive 4 weeks of 14mg and 4 weeks of 7mg nicotine patches. Participants who report complete abstinence from smoking and nicotine in the 3 days before C-NRT distribution will receive 8 weeks of 7mg nicotine patches.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
10.3%
24/232 • Number of events 24 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Nervous system disorders
Dizziness
|
4.3%
10/232 • Number of events 10 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Headache
|
4.7%
11/232 • Number of events 14 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Weakness
|
3.4%
8/232 • Number of events 8 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Heartburn
|
1.7%
4/232 • Number of events 4 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.0%
7/232 • Number of events 7 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
5.2%
12/232 • Number of events 13 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Hiccup
|
2.2%
5/232 • Number of events 5 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.86%
2/232 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Gas
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Cardiac disorders
Rapid, Slow, Pounding or Irregular Heartbeat
|
0.86%
2/232 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Skin and subcutaneous tissue disorders
Itching or Hives
|
2.2%
5/232 • Number of events 6 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Swelling or tingling in mouth or throat
|
3.0%
7/232 • Number of events 8 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Chest Tightness
|
0.86%
2/232 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Trouble Breathing
|
3.0%
7/232 • Number of events 7 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Rash, Irritation, or Swelling
|
3.0%
7/232 • Number of events 7 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Nervous system disorders
Insomnia/Distrupted Sleep/Vivid Dreams
|
14.2%
33/232 • Number of events 38 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Changes in Mood/Agitation or Distress
|
7.3%
17/232 • Number of events 17 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
General disorders
Suicidal Ideation
|
0.86%
2/232 • Number of events 2 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
|
Nervous system disorders
Seizure
|
0.43%
1/232 • Number of events 1 • All participants were assessed for adverse events at all study visits over the course of 10 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place