Clinical Trial

The Options 2 Study

Recruiting Phase 4
View on ClinicalTrials.gov →
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
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-09-10; most recent amendment 2026-06-17.
Status change: Not Yet Recruiting → Recruiting 2025-05-22
Trial Details
NCT Number NCT06595459
Lead Sponsor University of Wisconsin, Madison
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions Smoker, Smoking Cessation
Enrollment 300 participants
Start Date 2025-05-21
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22