A Phase 4 interventional study of Nicotine Pouches and Mini Nicotine lozenges in Smoker and Smoking Cessation, 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 2026-06-22.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.
Participants will:
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's planned enrollment of 300 is above the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will use 3mg nicotine pouches
Drug: Nicotine Pouches
Participants will use 6mg nicotine pouches
Drug: Nicotine Pouches
Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg)
Drug: Mini Nicotine lozenges
Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.
nicotine pouches
Also known as: ZYN
mini lozenges
Mean number of cigarettes smoked per day during the 21-day switching period.
Participants will self-report on their cigarette use
Time frame: Baseline to 3 weeks
Change in cigarette craving
Participants will rate their craving for a cigarette using a 0-100 visual analog scale, where 0 = no craving and 100 = extreme craving after sampling their assigned study product after overnight abstinence from smoking
Time frame: Baseline to 3 weeks
Mean units of study product used per day during the 7-days prior to the switching period
Participants will report their study product use via EMA
Time frame: For 7-days leading up to the switching period
Mean units of study product used per day during the 21-day of the switching period
Participants will report their study product use via EMA
Time frame: 21-days of the switching period
Plan to share: No
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University of Wisconsin, Madison