SmokerPhase 4NCT06595459
The Options 2 Study
A Phase 4 study testing Nicotine Pouches and Mini Nicotine lozenges in people with Smoker and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoker, Smoking Cessation
- What is being tested?
- Nicotine Pouches and Mini Nicotine lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 30 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Megan Piper, PhD, 608-265-5472, mep@ctri.wisc.edu
About this study
Official title: A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
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
Read the detailed description
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.
- Conditions
- Smoker, Smoking Cessation
- Being tested
- Nicotine Pouches, Mini Nicotine lozenges
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PouchesDrug
Also called ZYN
nicotine pouches
Mini Nicotine lozengesDrug
mini lozenges
| Study group | Role | What they receive |
|---|---|---|
| 3mg Nicotine Pouches | Experimental | Participants will use 3mg nicotine pouches Receives: Drug: Nicotine Pouches |
| 6mg Nicotine Pouches | Experimental | Participants will use 6mg nicotine pouches Receives: Drug: Nicotine Pouches |
| Nicotine Mini Lozenges | Experimental | Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg) Receives: Drug: Mini Nicotine lozenges |
| No Study Product | No intervention | Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of cigarettes smoked per day during the 21-day switching period.
Participants will self-report on their cigarette use
Measured: Baseline to 3 weeks
Secondary outcomes (3)
Change in cigarette craving
Participants will rate their craving for a cigarette using a 0-100 visual analog scale, where 0 = no craving and 100 = extreme craving after sampling their assigned study product after overnight abstinence from smoking
Measured: Baseline to 3 weeks
Mean units of study product used per day during the 7-days prior to the switching period
Participants will report their study product use via EMA
Measured: For 7-days leading up to the switching period
Mean units of study product used per day during the 21-day of the switching period
Participants will report their study product use via EMA
Measured: 21-days of the switching period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 May 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Megan Piper, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595459
- Sponsor's protocol ID
- 2024-1016
- Other IDs
- A534253, Protocol Version 8/22/25, 1R01CA291761-01
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health
- ClinicalTrials.gov ID
- NCT06595459
- Acronym / sponsor ID
- 2024-1016
- Conditions
- Smoker, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3mg Nicotine Pouches | Experimental | Drug: Nicotine PouchesParticipants will use 3mg nicotine pouches |
| 6mg Nicotine Pouches | Experimental | Drug: Nicotine PouchesParticipants will use 6mg nicotine pouches |
| Nicotine Mini Lozenges | Experimental | Drug: Mini Nicotine lozengesParticipants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg) |
| No Study Product | No intervention | –Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine PouchesAlso: ZYNnicotine pouches | Drug | 3mg Nicotine Pouches, 6mg Nicotine Pouches |
| Mini Nicotine lozengesmini lozenges | Drug | Nicotine Mini Lozenges |
Primary outcome
Mean number of cigarettes smoked per day during the 21-day switching period.
Time frame: Baseline to 3 weeks
Participants will self-report on their cigarette use
3 secondary outcomes
Change in cigarette craving
Time frame: Baseline to 3 weeks
Mean units of study product used per day during the 7-days prior to the switching period
Time frame: For 7-days leading up to the switching period
Mean units of study product used per day during the 21-day of the switching period
Time frame: 21-days of the switching period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Piper, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Pouches and Mini Nicotine lozenges in people with Smoker and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Piper, PhD (608-265-5472, mep@ctri.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of cigarettes smoked per day during the 21-day switching period. (time frame: Baseline to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.