The Options 2 Study

Recruiting now · Phase 4

Conditions studied: Smoker, Smoking Cessation

In brief

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

Key facts

Study ID

NCT06595459

Run by

University of Wisconsin, Madison

People needed

300

Starts

2025-05-21

Expected to finish

2029-07-30

Last updated by the study team

2026-06-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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 is running

• University of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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