UW Withdraw From Tobacco Study

Phase 2

Completed

Conditions: Tobacco Dependence

Interventions: Drug: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)

Registration Number: NCT04969198

Lead Sponsor: University of Wisconsin, Madison

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 232

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine Patch + Nicotine Mini Lozenge	Combination nicotine replacement therapy (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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 : 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 : 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: 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.
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.