Investigating nicotine pouches and mini lozenges as alternatives to smoking
A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
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 |
| Enrollment | 300 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06595459 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in evaluating nicotine replacement therapies, but this specific approach comparing pouches and lozenges is relatively novel.
Eligibility criteria
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 this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.