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To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.
This study will assess the use, nicotine delivery, subjective response, and sensory appeal of an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes | Experimental | Participants will use each product for up to a 30 minute interval But will also be permitted to stop use before the end of the 30-minute ad lib use period |
|
| Order 2 - Electronic Cigarettes and Oral Nicotine product | Experimental | Participants will use each prodcut for up to 30 minutes but will also be permitted to stop use before the end of the 30-minute ad lib use period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Cigarette | Other | Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nicotine boost | will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration | up to week 4 |
| Change in sensory response | will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely). | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change is stress markers | Saliva will be collected before and after product use of each product to establish plasma nicotine concentrations | Up to 4 weeks |
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Inclusion Criteria:
Current daily cigarette smoker as determined by:
a. Uses >=5 units/day for >=1 year
b. Uses portioned moist snuff, loose moist snuff and/or nicotine patches
Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide < 10ppm).
Self-report fair or better physical health.
Self-report fair or better mental health.
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related products
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maciej Goniewicz, PhD | Roswell Park Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
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| Oral Nicotine Pouch | Other | Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes. |
|
|
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012907 | Smoking |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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