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| ID | Type | Description | Link |
|---|---|---|---|
| A534253 | Other Identifier | UW Madison | |
| Protocol Version 8/22/25 | Other Identifier | UW Madison | |
| 1R01CA291761-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3mg Nicotine Pouches | Experimental | Participants will use 3mg nicotine pouches |
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| 6mg Nicotine Pouches | Experimental | Participants will use 6mg nicotine pouches |
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| Nicotine Mini Lozenges | Experimental | Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg) |
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| No Study Product | No Intervention | Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Pouches | Drug | nicotine pouches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of cigarettes smoked per day during the 21-day switching period. | Participants will self-report on their cigarette use | Baseline to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 3 weeks |
| Mean units of study product used per day during the 7-days prior to the switching period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Piper, PhD | Contact | 608-265-5472 | mep@ctri.wisc.edu | |
| Mark Zehner | Contact | 608-262-7568 | mark.zehner@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan Piper, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Mini Nicotine lozenges | Drug | mini lozenges |
|
Participants will report their study product use via EMA |
| 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 | 21-days of the switching period |