Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Study Overview
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Brief Summary
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The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.

Official Title
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Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Conditions
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Tobacco Use

Intervention / Treatment
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* Other: oral nicotine pouch - 2 mg
* Other: oral nicotine pouch - 4 mg
* Other: oral nicotine pouch - 8 mg
* Other: Smokeless tobacco


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (determined by self-report) Between the ages of 18-55 Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required Agree to use designated products according to study protocol Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use Exclusion Criteria: The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use Not providing answers to questions related to inclusion/exclusion criteria Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening Weigh less than 110 pounds Intend to quit tobacco/nicotine use in the next 30 days

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of oral nicotine pouch - 2 mg<br>On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes. | Other: oral nicotine pouch - 2 mg<br>* On brand oral nicotine pouch with 2 mg of protonated nicotine in original flavor<br>|
| Experimental: Use of oral nicotine pouch - 4 mg<br>On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes. | Other: oral nicotine pouch - 4 mg<br>* On brand oral nicotine pouch with 4 mg of protonated nicotine in original flavor<br>|
| Experimental: Use of oral nicotine pouch - 8 mg<br>On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes. | Other: oral nicotine pouch - 8 mg<br>* On brand oral nicotine pouch with 8 mg of protonated nicotine in original flavor<br>|
| Active Comparator: Use of smokeless tobacco<br>On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes. | Other: Smokeless tobacco<br>* Participant's typical brand of smokeless tobacco<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma nicotine concentration | Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline | Baseline to the end of the session, approximately 4 hours |