Determination of Liquid Flavor and Nicotine Form Outcomes

Study Overview
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Brief Summary
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The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.

Detailed Description
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In this study, participants will be asked to do the following: After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits. Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours. Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit). During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette. In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.

Official Title
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Determination of Liquid Flavor and Nicotine Form Outcomes

Conditions
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Electronic Cigarettes

Intervention / Treatment
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* Other: E-cigarette with sweetness type 1 and pronation level 1
* Other: E-cigarette with sweetness type 1 and pronation level 2
* Other: E-cigarette with sweetness type 2 and pronation level 1
* Other: E-cigarette with sweetness type 2 and pronation level 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy (determined by self-report) between the ages of 18-65 willing to provide informed consent use cigarettes, e-cigarettes, or both able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol Exclusion Criteria: women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening existence of any condition contraindicated for this study protocol as determined by study leadership Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will participate in 5 sessions. Sessions differ by the tobacco product used (see study arms). The sessions will be ordered by latin-square; however, session order is NOT expected to change any outcomes and order effects are not relevant to the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cigarette and/or e-Cigarette users<br>Each participant will participate in 4 sessions. During each session, participants will first complete a 10-puff product use period with the ECIG assigned for that session, then a 30-minute ad lib product use period, and then a cigarette/e-cigarette challenge paradigm. | Other: E-cigarette with sweetness type 1 and pronation level 1<br>* An open system ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1.<br>Other: E-cigarette with sweetness type 1 and pronation level 2<br>* An open system ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2.<br>Other: E-cigarette with sweetness type 2 and pronation level 1<br>* An open system ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1.<br>Other: E-cigarette with sweetness type 2 and pronation level 2<br>* An open system ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2.<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 examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage. | Baseline (approx 90 min after session start) to after final product usage (up to 165 min) | 
| Puff volume | The volume of each puff, in ml, averaged over each product use bout. | Through the final product use (up to 165 min) | 
| Puff duration | The duration of each puff, in ml, averaged over each product use bout. | Through the final product use (up to 165 min) | 
| Challenge paradigm latency | The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product. | at the end of the challenge paradigm, approx. 165 min | 
| Challenge paradigm puffs | The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes. | at the end of the challenge paradigm, approx. 165 min |