Status:
RECRUITING
The Options 2 Study
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Smoker
Smoking Cessation
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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 alterna...
Detailed Description
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effe...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06595459
Start Date
May 21 2025
End Date
July 30 2029
Last Update
September 4 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705