A Phase 4 interventional study of Varenicline and Nicotine patch in Smoking Cessation and Electronic Cigarette Use, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.
To be efficient and maximize translation potential, the investigators will use the efficient Multiphase Optimization Strategy (MOST) to identify an optimal intervention to help people who use both cigarettes and ENDS quit smoking cigarettes. As such, in this randomized 2x2x2 factorial screening trial, the investigators will examine three intervention components:
The Dual Focused counseling approach will encourage participants to quit their ENDS use as part of their smoking cessation attempt. The Smoking Focused counseling approach will encourage participants to quit smoking but not vaping and to use their ENDS strategically to deal with urges in service of harm reduction. There is theoretical and empirical support for these pharmacologic and counseling approaches and intensities.
Participants (N=500) will be dual users of cigarettes (>4 cigs/day for the last 6 months) and ENDS (vape weekly for at least 6 months) who are motivated to quit smoking and willing try to quit vaping, if asked to do so. Participants will be recruited, assessed, and treated remotely. They will be randomized to receive either varenicline or nicotine patches for 12 weeks, to receive either one or four 15-20-minute counseling sessions, and to receive counseling that is either dual focused or smoking focused. Dual Focused Cessation will focus on quitting both smoking and vaping on the target quit date (TQD). Pre-TQD, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places or at specific times of day). Post-TQD, participants will focus on building smoking and vaping cessation skills (e.g., coping with cravings to smoke or vape, avoiding smoking and vaping cues). Smoking Focused Cessation will focus on quitting smoking on the TQD and using ENDS as a behavioral substitute (i.e., using ENDS as a cigarette substitute). Pre-TQD, participants will be instructed to change smoking patterns (e.g., vaping rather than smoking in specific places or at specific times of day, vaping first in the morning rather than smoking) and practice smoking cessation coping strategies (e.g., substituting ENDS for cigarettes, avoiding smoking cues). Participants will be advised to quit smoking on the TQD and not worry about quitting vaping at this point. Participants will complete daily measures of smoking, vaping, and potential change mechanisms (e.g., craving, smoking reward, self-efficacy) via ecological momentary assessment (EMA) for 2 weeks pre-TQD and 2 weeks post-TQD. Follow-up will occur for 12 months post-TQD.
Primary Objective: Determine which pharmacologic and counseling approaches are especially effective, alone or in combination, in helping dual users quit smoking.
Secondary Objectives:
Examine
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 500 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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The criteria were revised on the registry on Oct 7, 2026. See what changed
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Exclusion Criteria:
Drug: Varenicline · Behavioral: Dual Focused Cessation Counseling · Other: Counseling Intensity: 1 Session
Drug: Varenicline · Behavioral: Dual Focused Cessation Counseling · Other: Counseling Intensity: 4 Sessions
Drug: Varenicline · Behavioral: Smoking Focused Cessation Counseling · Other: Counseling Intensity: 1 Session
Drug: Varenicline · Behavioral: Smoking Focused Cessation Counseling · Other: Counseling Intensity: 4 Sessions
Drug: Nicotine patch · Behavioral: Dual Focused Cessation Counseling · Other: Counseling Intensity: 1 Session
Drug: Nicotine patch · Behavioral: Dual Focused Cessation Counseling · Other: Counseling Intensity: 4 Sessions
Drug: Nicotine patch · Behavioral: Smoking Focused Cessation Counseling · Other: Counseling Intensity: 1 Session
Drug: Nicotine patch · Behavioral: Smoking Focused Cessation Counseling · Other: Counseling Intensity: 4 Sessions
0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily
Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.
Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).
Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).
Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
Participants assigned to intensive counseling will have four, 15-20-minute sessions.
52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
52-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes
Time frame: up to 52 weeks
26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
26-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes
Time frame: up to 26 weeks
7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD
Biochemically confirmed with saliva cotinine \<30 ng/mL
Time frame: up to 52 weeks
Number of Participants Achieving Initial Smoking Abstinence
Measured by self-reported 24-hours of cigarette abstinence within the first 2 weeks of the target quit day
Time frame: up to 2 weeks
12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
12-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes
Time frame: up to 12 Weeks (end of treatment)
7-day point-prevalence abstinence from smoking and vaping at Week 12
Biochemically confirmed with saliva cotinine \<30 ng/mL
Time frame: up to 12 Weeks (end of treatment)
Number of Participants Achieving Initial Abstinence from Smoking and Vaping
Measured by self-reported 24-hours of cigarette and ENDS abstinence within the first 2 weeks of the target quit day
Time frame: up to 2 weeks
Number of days until first cigarette following initial cessation
Latency to lapse (number of days until first cigarette following initial cessation) computed over the full 52 weeks post-TQD
Time frame: up to 52 weeks post-TQD
Number of days until 7 consecutive days of smoking following initial cessation
Latency to relapse (number of days until 7 consecutive days of smoking following initial cessation) computed over the full 52 weeks post-TQD.
Time frame: up to 52 weeks post-TQD
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Varenicline · Nicotine Patch
University of Wisconsin, Madison →