Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

Study Overview
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Brief Summary
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This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) vaping, while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults (youth). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

Detailed Description
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We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.

Official Title
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Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

Conditions
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E-cigarette Use

Intervention / Treatment
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* Other: ECIG lab session 1
* Other: ECIG lab session 2
* Other: ECIG lab session 3
* Other: ECIG lab session 4
* Other: ECIG lab session 5
* Other: ECIG lab session 6
* Other: ECIG lab session 7
* Other: ECIG lab session 8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine) 21-25 years old Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions Willing to complete five, 6 hour lab visits Able to read and speak English Willing to provide informed consent Exclusion Criteria: Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease Unstable or significant psychiatric conditions (past and stable conditions will be allowed) History of cardiac event or distress within the past 3 months Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding Use of other tobacco products > 5 days in the past month Current marijuana use > 5 times per month Currently engaging in a vaping cessation attempt Ohio State University (OSU) verifies study project 2 current membership/past participation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 25 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High concentration free-base nicotine (5%), Tobacco flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 1<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: High concentration nicotine salt (5%), Tobacco flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 2<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: High concentration free-base nicotine (5%), Menthol flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 3<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: High concentration nicotine salt (5%), Menthol flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 4<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: Low concentration free-base nicotine (1%), Tobacco flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 5<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: Low concentration nicotine salt (1%), Tobacco flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 6<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: Low concentration free-base nicotine (1%), Menthol flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 7<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|
| Experimental: Low concentration nicotine salt (1%), Menthol flavor<br>Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. | Other: ECIG lab session 8<br>* vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma nicotine concentration | Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min. | 0, 5, 10, 35 min. | 
| Puff count | E-cig puff topography data collection for abuse liability | 35 minutes | 
| Average Puff duration | E-cig puff topography data collection for abuse liability | 35 minutes | 
| Average Puff volume | E-cig puff topography data collection for abuse liability | 35 minutes | 
| Lung function assessment | Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breathes. Measures amount inhaled and how quickly exhaled. | 35 minutes | 
| Airway Inflammation (NIOX VERO) | Physiological effects of pulmonary function collected from inhaled and exhaled breathes | 35 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory E-Cigarette Expectancies Scale (SEES) | Background measures. Range 0-4 from never to almost always. | Baseline | 
| Timeline Followback (TLFB) | Background measures | Baseline | 
| modified Cigarette Dependence Scale | Background measures | Baseline | 
| Drug Effects/Liking Questionnaire | Subjective effects measures | 35 minutes | 
| modified Cigarette Evaluation Questionnaire (mCEQ) | Subjective effects measures. Range 0-6 from not at all to Extremely. | 35 minutes | 
| E-cigarette Purchase Task | Behavioral economic demand | 35 minutes | 
| Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form | E-cig craving/suppression of craving and withdraw | 0, 5, 10, 35 min. | 
| Vascular reactivity | Endothelial function will be collected through EndoPAT device along with other cardiovascular measures. | 30 minutes |