Nicotine pouches versus lozenges or no product to help daily cigarette smokers switch

A randomized comparative effectiveness trial of nicotine pouches for cigarette substitution: A question of public health

NIH-funded research University of Wisconsin-Madison · NIH-11173898

This trial compares nicotine pouches (two doses), nicotine mini-lozenges, and no product to see which helps adults who smoke daily reduce or replace cigarettes.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Wisconsin-Madison NIH-funded
Lab location1 site (Madison, United States)
Project IDNIH-11173898 on NIH RePORTER

What this research studies

You would join a group of 284 adults who smoke every day and are not planning to quit soon; participants are randomly assigned to one of four groups: 3-mg nicotine pouches, 6-mg nicotine pouches, nicotine mini-lozenges (2- or 4-mg), or no study product. The study will track product use, cigarette smoking behavior, and biological markers over time to see whether and how people switch from cigarettes to a less harmful nicotine product. Investigators will examine the role of nicotine dose and other factors that help or hinder switching, using visits, questionnaires, and likely mobile app check-ins. The focus is on real-world substitution of cigarettes with pouches or lozenges among adult smokers.

Who could benefit from this research

Good fit: Adults aged 21 and older who smoke cigarettes daily and are not planning to quit in the next 30 days are the intended participants.

Not a fit: People under 21, non-daily smokers, or those already planning to quit immediately are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, this could offer a lower-risk nicotine option that helps people who smoke reduce exposure to harmful cigarette smoke and lower cancer risk.

How similar studies have performed: Traditional nicotine replacement therapies and some e-cigarette trials have helped smokers switch, but nicotine pouches are a newer product with limited prior evidence.

Where this research is happening

Madison, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Cancers
Last reviewed 2026-06-13 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.