drugset / Trial / NCT06595459
The Options 2 Study
Phase 4
Recruiting
300 enrolled
University of Wisconsin, Madison
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2025-05-21
- Primary completion
- 2029-01-01
- Completion
- 2029-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mini Nicotine lozenges | Unknown | 2 mg | — |
| Subject | Mini Nicotine lozenges | Unknown | 4 mg | — |
| Subject | Nicotine Pouches | Unknown | 3 mg | — |
| Subject | Nicotine Pouches | Unknown | 6 mg | — |
Indications
No indication recorded.