Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

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 cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Official Title
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Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

Conditions
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Electronic Cigarettes

Intervention / Treatment
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* Other: ECIG Lab Session 15 watts, 10 mg nicotine
* Other: ECIG Lab Session 15 watts, 15 mg nicotine
* Other: ECIG Lab Session 15 watts, 30 mg nicotine
* Other: ECIG Lab Session 30 watts, 10 mg nicotine
* Other: ECIG Lab Session 30 watts, 15 mg nicotine
* Other: ECIG Lab Session 30 watts, 30 mg nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria--participants must be: 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. Individuals who weigh less than 110 pounds 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cigarette smokers<br> | Other: ECIG Lab Session 15 watts, 10 mg nicotine<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>Other: ECIG Lab Session 15 watts, 15 mg nicotine<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>Other: ECIG Lab Session 15 watts, 30 mg nicotine<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>Other: ECIG Lab Session 30 watts, 10 mg nicotine<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>Other: ECIG Lab Session 30 watts, 15 mg nicotine<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>Other: ECIG Lab Session 30 watts, 30 mg nicotine<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>|
| Active Comparator: Electronic cigarette users<br> | Other: ECIG Lab Session 15 watts, 10 mg nicotine<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>Other: ECIG Lab Session 15 watts, 15 mg nicotine<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>Other: ECIG Lab Session 15 watts, 30 mg nicotine<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>Other: ECIG Lab Session 30 watts, 10 mg nicotine<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>Other: ECIG Lab Session 30 watts, 15 mg nicotine<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>Other: ECIG Lab Session 30 watts, 30 mg nicotine<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 |
| --- | --- | --- |
| Change in Plasma Nicotine | Change in plasma nicotine level. | Baseline to 5 min after the start of a 10-puff product use | 
| Puff Volume | The average volume of each puff, in ml, during 10 puff bout. | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes | 
| Puff Duration | The average duration of each puff, in seconds. | Each time the e-cigarette is used during the 10-puff use bout - 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Average heart rate, measured in beats per minute. | Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes |