UW Withdraw From Tobacco Study

Study Overview
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Brief Summary
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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).

Official Title
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UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Patch + Nicotine Mini Lozenge<br>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) | Drug: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)<br>* 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.<br>* Other names: C-NRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | 9 weeks after quit date | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) | 
| 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. | pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks) |