Investigating nicotine pouches and mini lozenges as alternatives to smoking
Official title: A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
Run by University of Wisconsin, Madison · NCT06595459 · Data updated 2026-11-12
This study is testing if nicotine pouches and mini lozenges can help smokers who aren't ready to quit cigarettes yet by giving them alternatives to try for a week.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | May 21, 2025 |
| Main results expected | January 1, 2029 |
| Study ends | July 30, 2029 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT06595459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who smoke at least 5 cigarettes daily and are not planning to quit smoking within the next 30 days.
✕Probably not a fit
Patients currently undergoing treatment for psychosis or bipolar disorder, or those who are pregnant or breastfeeding, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of nicotine pouches and mini lozenges as substitutes for cigarettes among smokers who are not planning to quit in the near future. Participants will use either nicotine pouches, mini lozenges, or no product for one week, followed by a three-week period of attempting to abstain from smoking. The study includes six in-person visits and utilizes a smartphone app for tracking smoking behavior and product use. By comparing these products, the trial seeks to provide valuable data on their potential public health benefits and inform tobacco regulatory policies.
Why it matters
Potential benefit: If successful, this study could provide smokers with effective alternatives to cigarettes, potentially reducing smoking rates and improving public health.
How similar studies have gone: Other studies have shown promise in evaluating nicotine replacement therapies, but this specific approach comparing pouches and lozenges is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 21 years old (i.e., able to legally purchase tobacco products) * able to read and communicate in English * no plans to quit smoking in the next 30 days * willing to stop using nicotine replacement or varenicline * willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation * smoking ≥ 5 cigarettes per day for the past 6 months * exhaled carbon monoxide ≥ 6 ppm * no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months Exclusion Criteria: * currently in treatment for psychosis or bipolar disorder * currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression) * currently pregnant or breastfeeding
Where it's running
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University of Wisconsin
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Megan Piper, PhD — University of Wisconsin, Madison
- Study coordinator: Megan Piper, PhD
- Email: mep@ctri.wisc.edu
- Phone: 608-265-5472
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.