Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 21 and up

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.

More Smoking Cessation trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages21 Years and up
SexAll
Enrollment300 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedMay 21, 2025
Main results expectedJanuary 1, 2029
Study endsJuly 30, 2029
Registry record updatedJune 22, 2026
Trial IDNCT06595459 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.