The Options 2 Study
A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
University of Wisconsin, Madison
300 participants
May 21, 2025
INTERVENTIONAL
Conditions
Summary
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: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use
Eligibility
Inclusion Criteria8
- ≥ 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 Criteria3
- 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
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Interventions
3mg or 6mg nicotine pouches
2mg to 4mg mini lozenges
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06595459