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

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.

Study Overview

• Status: Completed
• Conditions: E-cigarette Use
• Intervention / Treatment: 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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High concentration free-base nicotine (5%), Tobacco flavor; 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; 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.
Experimental: High concentration nicotine salt (5%), Tobacco flavor; 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; 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.
Experimental: High concentration free-base nicotine (5%), Menthol flavor; 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; 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.
Experimental: High concentration nicotine salt (5%), Menthol flavor; 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; 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.
Experimental: Low concentration free-base nicotine (1%), Tobacco flavor; 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; 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.
Experimental: Low concentration nicotine salt (1%), Tobacco flavor; 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; 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.
Experimental: Low concentration free-base nicotine (1%), Menthol flavor; 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; 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.
Experimental: Low concentration nicotine salt (1%), Menthol flavor; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.	30 minutes
Average Puff Duration	E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.	30 minutes
Average Puff Volume	E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.	30 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 breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)	Baseline and 35 minutes
Airway Inflammation (NIOX VERO)	Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.	35 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory E-Cigarette Expectancies Scale (SEES)	Background measures. Comprised of 9 items each of which range 0-4 from "never" to "almost always". The 3 subscales (enjoyment of taste and smell, pleasurable physical sensations, enjoyment of vapor cloud production) are the average of 3 items each; scores range from 0 to 4 with higher scores indicating greater enjoyment.	Baseline
Modified Cigarette Dependence Scale	Assess e-cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.	Baseline
Drug Effects/Liking Questionnaire	An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying.	35 minutes
Modified Cigarette Evaluation Questionnaire (mCEQ)	The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to e-cigarettes (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.	35 minutes
E-cigarette Purchase Task - Breakpoint	Behavioral economic demand Asks participants how much they would be willing to pay (ranging from 0¢ to $1,120) for a puff of their study product. Specifically they will be asked, "Thinking about the study product, how many puffs of e-cigarette would you smoke if they were each at the following prices?". Breakpoint is the first price of zero consumption.	35 minutes
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form	E-cig craving/suppression of craving and withdraw will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges (QSU): Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette"). This is a 10-item measure where participants rate smoking/vaping-related items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.	0, 5, 10, 35 min.
Vascular Reactivity	Endothelial function will be collected through EndoPAT device. Specifically, the natural log of RHI, the reactive hyperemia index, will be recorded. The RHI (Reactive Hyperemia Index) or LnRHI (natural log of RHI) is the post-to-pre occlusion PAT™ signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone. Values less than 1.67 or higher than 0.51 are considered to be abnormal.	Pre-Vaping Session at Visit 1

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Marielle Brinkman, BS, Ohio State University; Principal Investigator: Theodore L Wagener, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OSU-20313; NCI-2021-06437 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No