Smoker study: Nicotine Pouches vs Mini Nicotine lozenges
Official title The Options 2 Study
ClinicalTrials.gov ID: NCT06595459
What this study is testing
What is Nicotine Pouches?
Nicotine pouches are being studied to see if they can help smokers switch away from cigarettes. is designed to deliver nicotine through the mouth lining to help reduce the urge to smoke.
Also referred to as ZYN.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether nicotine pouches or mini lozenges can replace cigarettes when you try to quit. It also looks at how well they work and how safe they are.
- Who it's for
- You may be able to join if you are a smoker who wants to stop smoking.
- What's involved
- You will use either nicotine pouches, mini lozenges, or no product for one week, then try not to smoke for three weeks. You will visit the clinic six times and have one phone call, fill out questionnaires, and use a smartphone app to track your use.
- Time commitment
- The study lasts about four weeks, with six clinic visits and one follow‑up call.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- ≥ 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
- willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
You likely can't join if
- 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
See the full eligibility criteria
- ≥ 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
- willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
- smoking ≥ 5 cigarettes per day for the past 6 months
- exhaled carbon monoxide ≥ 6 ppm
- no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.