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The Options 2 Study

A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health

Who can join

Ages 21 and older · All sexes

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

About the study

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

What is being tested

• Nicotine Pouches (drug)
• Mini Nicotine lozenges (drug)

Sponsor: University of Wisconsin, Madison · Participants: 300 · Started: May 21, 2025

Contact the study team

• Megan Piper, PhD · Phone: 608-265-5472
• Mark Zehner · Phone: 608-262-7568

Official record on ClinicalTrials.gov — NCT06595459

Locations in the U.S.

Conditions

• Quitting Smoking

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.