Nicotine Pouches for Smoking Cessation
(Pack2Pouch Trial)
Trial Summary
If you are currently using smoking cessation medications like varenicline, bupropion, or nicotine replacement therapy, you will need to stop taking them to participate in this trial.
Research suggests that nicotine pouches, like Zonnic, can help reduce withdrawal symptoms and are considered a low-risk alternative to cigarettes. They may be as effective as other nicotine replacement therapies, such as gum, in helping people quit smoking.
12345There is limited safety data on nicotine pouches, but they are considered a low-risk alternative to cigarettes and traditional smokeless tobacco. However, more research is needed to fully understand their health impacts.
16789Nicotine pouches are a novel, tobacco-free oral product that provides nicotine without the harmful chemicals found in traditional tobacco products, making them a potentially lower-risk alternative for smokers. Unlike nicotine gum or patches, these pouches are discreet and do not require chewing or sticking to the skin, offering a different method of nicotine delivery.
14568Eligibility Criteria
This trial is for individuals who are currently cigarette smokers and want to switch to a less harmful alternative. Participants will be asked to use tobacco-free nicotine pouches with varying nicotine levels over 4 weeks, provide breath and cheek swab samples, and answer questions about their tobacco use.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 28-day supply of nicotine pouches and are asked to switch from smoking to pouches over 4 weeks
Follow-up
Participants are monitored for smoking reduction and switching to nicotine pouches
Participant Groups
Nicotine Pouches is already approved in United States, European Union for the following indications:
- Smoking cessation aid
- Nicotine replacement therapy
- Smoking cessation aid
- Nicotine replacement therapy