RecruitingPhase 4

The Options 2 Study

United States300 participantsStarted 2025-05-21

Plain-language 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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean number of cigarettes smoked per day during the 21-day switching period.

Timeframe: Baseline to 3 weeks

Trial details

NCT IDNCT06595459

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Megan Piper, PhD

608-265-5472 mep@ctri.wisc.edu

View on ClinicalTrials.gov More Smoker trials