Assessing Electronic Cigarette Nicotine Flux

Study Overview
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Brief Summary
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The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.

Official Title
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Assessing Electronic Cigarette Nicotine Flux

Conditions
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Electronic Cigarette Use

Intervention / Treatment
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* Other: ECIG Lab Session, 30 watts


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 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. 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: 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
Interventional Model Description: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cigarette Smokers: 0 mg/ml nicotine concentration<br>ECIG Lab Session, 30 watts, 0 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. | Other: ECIG Lab Session, 30 watts<br>* During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.<br>|
| Experimental: Cigarette Smokers: 4 mg/ml nicotine concentration<br>ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. | Other: ECIG Lab Session, 30 watts<br>* During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.<br>|
| Experimental: Cigarette Smokers: 15 mg/ml nicotine concentration<br>ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. | Other: ECIG Lab Session, 30 watts<br>* During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.<br>|
| Experimental: Cigarette Smokers: 30 mg/ml nicotine concentration<br>ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout. | Other: ECIG Lab Session, 30 watts<br>* During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Nicotine Concentration | Change in plasma nicotine concentration Blood will be taken 5 times in each session to examine changes from baseline (approx. 90 minutes) to immediately follow a ten-puff bout (approx. 100, 120, and 190 minutes), and immediately after the cigarette challenge paradigm (approx. 205 minutes). | Approximately 205 minutes | 
| Cigarette Challenge Paradigm | The cigarette challenge paradigm is a procedure in which participants will be given a 5 minute time period in which they are allowed to smoke their own brand cigarette as much or as little as they want. Study staff will provide the participant with their own brand cigarettes, a lighter, and an ash tray. Latency to start the first puff and number of puffs will be recorded. | This task will occur at approximiately 200 minutes until 205 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puff volume | The volume of each puff, in ml. | Puff volume will be measured during the approximately 5-minute, 10-puff use bout. | 
| Puff duration | The duration of each puff, measured in second. | Puff duration will be measured during the approximately 5-minute, 10-puff use bout. |