Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking (NCT07625956) | Clinical Trial Compass
By InvitationPhase 4
Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking
United States10 participantsStarted 2026-06
Plain-language summary
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
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:
* Age 21 years or older
* Currently enrolled in and completed the Pack2Pouch parent study
* Current combustible tobacco smoking at extension study enrollment
* Able to attend in-person visits in the Charleston, SC area
* Access to internet and mobile communication
Exclusion Criteria:
* Pregnancy, breastfeeding, or nursing
* Medical contraindications to nicotine replacement therapy
* Current use of smoking cessation medications
* Non-English proficiency
* Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol
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.
1This trial is in Phase 4 and is testing nicotine pouches as a substitute for cigarette smoking — since Phase 4 studies happen after a product is already approved, what does that mean about how much is already known about the safety of nicotine pouches compared to cigarettes, and is this approach a realistic option for me?
2The trial is currently enrolling by invitation only — can you find out whether I might be eligible to be referred or invited, and what criteria are typically used to select participants?
3Since this study is mainly measuring whether the approach is feasible and acceptable rather than long-term quitting rates, would it give me a clear picture of whether nicotine pouches would actually help me quit smoking, or are there better-evidenced treatments I should consider first?
4How does using nicotine pouches as a smoking substitute compare to other quit-smoking strategies you'd recommend for my situation, such as nicotine replacement therapy, prescription medications, or behavioral counseling?
5If I were to participate in this trial, what would be expected of me day-to-day — for example, would I need to stop smoking immediately, track my pouch use, or attend regular check-ins — and is that realistic given my current lifestyle?
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.