Nicotine Pouches + Lozenges for Smoking Cessation
Trial Summary
Will I have to stop taking my current medications?
If you are using nicotine replacement, varenicline, or bupropion (only for smoking cessation), you will need to stop taking them to participate in the trial. If you are taking bupropion for other reasons, like depression, you cannot join the trial.
What data supports the effectiveness of the treatment Nicotine Pouches + Lozenges for Smoking Cessation?
Is the combination of nicotine pouches and lozenges safe for human use?
Research suggests that nicotine pouches, like ZYN, may be a lower-risk alternative to traditional tobacco products, but specific safety data for the combination of nicotine pouches and lozenges is not available. Nicotine lozenges have been used as a smoking cessation aid, and while they may have a low risk of abuse, especially among younger individuals, their safety profile is generally considered acceptable for smoking cessation.14678
How is the treatment with nicotine pouches and lozenges different from other smoking cessation options?
This treatment is unique because it uses tobacco-free nicotine pouches, which are placed between the lip and gum, offering a low-risk alternative to traditional tobacco products. Unlike other nicotine replacement therapies, these pouches come in various flavors and are marketed as a novel, discreet way to deliver nicotine without tobacco.19101112
What is the purpose of 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
Research Team
Megan Piper, PhD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
This trial is for individuals who are currently smoking and interested in quitting. Participants will try nicotine pouches or mini lozenges as alternatives to cigarettes. They must be willing to attend several research visits, complete questionnaires, and use a smartphone app to track their usage of products.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Product Use and Switching
Participants use nicotine pouches, mini lozenges, or no product for 1 week, then attempt to abstain from smoking for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after the switching period
Treatment Details
Interventions
- Mini Nicotine lozenges
- Nicotine Pouches
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator