Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

Conditions
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Tobacco Use, Tobacco Smoking, Cigarette Smoking, Smokeless Tobacco Cessation

Intervention / Treatment
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* Other: Electronic Cigarette
* Other: Oral Nicotine Pouch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current daily cigarette smoker as determined by: Smokes >5 cigarettes/day for >1 year OR Current daily smokeless tobacco or oral nicotine user 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: Currently uses other tobacco or nicotine products (e.g., ENDS) > 2 days/week. Self-report having active, untreated medical/psychiatric conditions History of serious side effects from nicotine or from any nicotine replacement therapies. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Nursing female participants. Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners. Unwilling or unable to follow protocol requirements. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug. Previous use of the study products (ZYN or Vuse Alto; on! or General Slims).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes<br>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 | Other: Electronic Cigarette<br>* 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.<br>* Other names: Vuse Alto;Other: Oral Nicotine Pouch<br>* Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.<br>* Other names: ZYN;|
| Experimental: Order 2 - Electronic Cigarettes and Oral Nicotine product<br>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 | Other: Electronic Cigarette<br>* 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.<br>* Other names: Vuse Alto;Other: Oral Nicotine Pouch<br>* Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.<br>* Other names: ZYN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |