Tobacco Dependence
Conditions
Brief summary
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings. Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).
Interventions
DRUGCombination 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smoke ≥5 cigarettes per day for past year * ≥21 years old * Able to read and write English * Desire to quit smoking * Not currently engaged in cessation treatment * Eligible to use combination nicotine replacement therapy * Willing and able to attend study visits * Have reliable smartphone access * Not currently pregnant, trying to get pregnant, or breastfeeding * Willing to respond to ecological momentary assessment prompts and other study activities * Baseline breath carbon monoxide (CO) ≥5ppm
Exclusion criteria
* Used pipe tobacco, cigars, snuff, or chew more than twice in the past week * Used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week * Unwilling to try to abstain from all non-medicinal nicotine use (including e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement therapy provided by the study) * Currently taking varenicline or bupropion * Allergy to adhesive tape * Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it * Unwilling to use study approved methods of birth control while taking study medication and for 1 month after discontinuing study medication \[only for women of child-bearing potential\] * Hospitalized for a stroke, heart attack, congestive heart failure, ulcers, or diabetes within the last year * History of seizure within the last year * Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar disorder within the last 5 years * End-stage renal disease * Suicide attempt or suicidal ideation within the last 12 months * Severe hypertension \> 180/100 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L) | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WSWS2-L Subscale Score : Concentration | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score : Sleep Problems | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score: Hunger | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score : Craving | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| 9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent | 9 weeks after quit date | 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. |
| Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS) | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score: Anhedonia | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score : Restlessness | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
| Change in WSWS2-L Subscale Score : Negative Affect | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 232 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Withdrawal by Subject | 20 |
| Overall Study | Withdrawn by PI for Participant Non-Compliance | 16 |
Baseline characteristics
| Characteristic | Nicotine Patch + Nicotine Mini Lozenge |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 184 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 221 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 187 Participants |
| Sex/Gender, Customized Female | 112 Participants |
| Sex/Gender, Customized Male | 116 Participants |
| Sex/Gender, Customized Other | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 232 |
| other Total, other adverse events | 96 / 232 |
| serious Total, serious adverse events | 8 / 232 |
Outcome results
Primary
Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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
Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 2 weeks pre-quit | 2.69 score on a scale | Standard Deviation 1.27 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 1 week pre-quit | 2.38 score on a scale | Standard Deviation 1.15 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 1-3 days pre-quit | 2.33 score on a scale | Standard Deviation 1.15 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 1-2 days post-quit | 2.74 score on a scale | Standard Deviation 1.25 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 1 week post-quit | 2.72 score on a scale | Standard Deviation 1.21 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Wisconsin Smoking Withdrawal Scale2 Brief Score | 2 weeks post-quit | 2.29 score on a scale | Standard Deviation 1.08 |
Secondary
9-Week Point-Prevalence Abstinence: Number of Participants Who Were 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.
Time frame: 9 weeks after quit date
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | 9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent | 46 Participants |
Secondary
Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS) | 2 weeks pre-quit | 0.965 score on a scale | Standard Deviation 0.89 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS) | 1 week pre-quit | 0.855 score on a scale | Standard Deviation 0.83 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | 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 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS) | 1 week post-quit | 1.2 score on a scale | Standard Deviation 0.95 |
| Nicotine Patch + Nicotine Mini Lozenge | 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
Change in WSWS2-L Subscale Score: Anhedonia
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 2 weeks pre-quit | 1.93 score on a scale | Standard Deviation 1.46 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 1 week pre-quit | 1.75 score on a scale | Standard Deviation 1.41 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 1-3 days pre-quit | 1.65 score on a scale | Standard Deviation 1.37 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 1-2 days post-quit | 1.91 score on a scale | Standard Deviation 1.5 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 1 week post-quit | 2.03 score on a scale | Standard Deviation 1.49 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Anhedonia | 2 weeks post-quit | 1.79 score on a scale | Standard Deviation 1.22 |
Secondary
Change in WSWS2-L Subscale Score : Concentration
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 2 weeks pre-quit | 1.94 score on a scale | Standard Deviation 1.28 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 1 week pre-quit | 1.73 score on a scale | Standard Deviation 1.11 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 1-3 days pre-quit | 1.74 score on a scale | Standard Deviation 1.28 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 1-2 days post-quit | 2.04 score on a scale | Standard Deviation 1.43 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 1 week post-quit | 2.18 score on a scale | Standard Deviation 1.56 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Concentration | 2 weeks post-quit | 1.86 score on a scale | Standard Deviation 1.17 |
Secondary
Change in WSWS2-L Subscale Score : Craving
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 2 weeks pre-quit | 4.55 score on a scale | Standard Deviation 1.75 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 1 week pre-quit | 4.12 score on a scale | Standard Deviation 1.75 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 1-3 days pre-quit | 3.98 score on a scale | Standard Deviation 1.75 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 1-2 days post-quit | 4.86 score on a scale | Standard Deviation 1.76 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 1 week post-quit | 4.47 score on a scale | Standard Deviation 1.8 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Craving | 2 weeks post-quit | 3.3 score on a scale | Standard Deviation 1.69 |
Secondary
Change in WSWS2-L Subscale Score: Hunger
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 2 weeks pre-quit | 2.39 score on a scale | Standard Deviation 1.46 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 1 week pre-quit | 2.19 score on a scale | Standard Deviation 1.38 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 1-3 days pre-quit | 2.06 score on a scale | Standard Deviation 1.23 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 1-2 days post-quit | 2.34 score on a scale | Standard Deviation 1.4 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 1 week post-quit | 2.44 score on a scale | Standard Deviation 1.42 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score: Hunger | 2 weeks post-quit | 2.39 score on a scale | Standard Deviation 1.39 |
Secondary
Change in WSWS2-L Subscale Score : Negative Affect
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 2 weeks pre-quit | 2.13 score on a scale | Standard Deviation 1.41 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 1 week pre-quit | 1.95 score on a scale | Standard Deviation 1.33 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 1-3 days pre-quit | 1.92 score on a scale | Standard Deviation 1.21 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 1-2 days post-quit | 2.35 score on a scale | Standard Deviation 1.48 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 1 week post-quit | 2.48 score on a scale | Standard Deviation 1.6 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Negative Affect | 2 weeks post-quit | 2.06 score on a scale | Standard Deviation 1.26 |
Secondary
Change in WSWS2-L Subscale Score : Restlessness
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 2 weeks pre-quit | 2.13 score on a scale | Standard Deviation 1.41 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 1 week pre-quit | 1.95 score on a scale | Standard Deviation 1.33 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 1-3 days pre-quit | 1.92 score on a scale | Standard Deviation 1.21 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 1-2 days post-quit | 2.35 score on a scale | Standard Deviation 1.48 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 1 week post-quit | 2.48 score on a scale | Standard Deviation 1.6 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Restlessness | 2 weeks post-quit | 2.06 score on a scale | Standard Deviation 1.26 |
Secondary
Change in WSWS2-L Subscale Score : Sleep Problems
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 2 weeks pre-quit | 2.73 score on a scale | Standard Deviation 1.63 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 1 week pre-quit | 2.35 score on a scale | Standard Deviation 1.44 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 1-3 days pre-quit | 2.24 score on a scale | Standard Deviation 1.47 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 1-2 days post-quit | 2.37 score on a scale | Standard Deviation 1.49 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 1 week post-quit | 2.55 score on a scale | Standard Deviation 1.58 |
| Nicotine Patch + Nicotine Mini Lozenge | Change in WSWS2-L Subscale Score : Sleep Problems | 2 weeks post-quit | 2.37 score on a scale | Standard Deviation 1.4 |