Switching to Potential Reduced Exposure Products in Adult Smokers

Study Overview
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Brief Summary
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This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

Official Title
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Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

Conditions
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Tobacco Use Disorder, Oral Nicotine Pouch Use, Smoking Behaviors, Harm Reduction, Toxic Effect of Tobacco and Nicotine, Carcinogenesis

Intervention / Treatment
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* Device: ZYN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel) English literate Smoke at least 1 cigarette per day Expired breath carbon monoxide level ≥ 6ppm at baseline Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline). Exclusion Criteria: Currently using any stop smoking treatments (2008 PHS Guideline Update Panel) History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia) Current uncontrolled medical condition Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation) Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study Severe lung disease that requires supplemental oxygen Uncontrolled asthma (<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year) Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year) Planning to quit smoking with a set goal or time for quit attempt Known hypersensitivity to propylene glycol Patients with an FEV1 < 40%

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3mg Nicotine Concentration<br>15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration. | Device: ZYN<br>* 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.<br>|
| Experimental: 6mg Nicotine Concentration<br>15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration. | Device: ZYN<br>* 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who switched from cigarettes to the ZYN Pouches. | To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations | This will be evaluated at week 4. | 
| Change in levels of biomarkers (nicotine, NNAL, CO) among smokers | Participants will provide repeated lab samples for biomarker assessments. Urine and breath carbon monoxide samples will be obtained at baseline, week 4, and week 8 (only if complete switching is reported). | from baseline up to week 4 | 
| Number of cigarettes smoked per day. | The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations | up to week 4 | 
| Percentage of smoke free days. | The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations | up to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Cigarette Evaluation Scale | To evaluate the acceptability of switching, participants will rate ZYN and how it compares to their preferred cigarettes. Additionally, participants will also be asked how likely it is that they will continue to use ZYN compared to cigarettes. The investigators will utilize items modified from the Modified Cigarette Evaluation Scale adapted for these subjective measures. To evaluate the feasibility of switching to ZYN, we will document how many participants switch entirely to ZYN. | week 4 |