The Options 2 Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nicotine Pouches
- Mini Nicotine lozenges
Treatment groups
300 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov