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

Not Applicable

Completed

Conditions: E-cigarette Use

Registration Number: NCT05458895

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Plasma Nicotine Concentration	0, 5, 10, 35 min.	Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.
Puff Count	30 minutes	E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.
Average Puff Duration	30 minutes	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.
Average Puff Volume	30 minutes	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.
Lung Function Assessment	Baseline and 35 minutes	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)
Airway Inflammation (NIOX VERO)	35 minutes	Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.

Secondary Outcome Measures

Name	Time	Method
Sensory E-Cigarette Expectancies Scale (SEES)	Baseline	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.
Modified Cigarette Dependence Scale	Baseline	Assess e-cigarette dependence. Scores range from 5 to 25 with higher scores indicating a greater level of dependence.
Drug Effects/Liking Questionnaire	35 minutes	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.
Modified Cigarette Evaluation Questionnaire (mCEQ)	35 minutes	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.
E-cigarette Purchase Task - Breakpoint	35 minutes	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.
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form	0, 5, 10, 35 min.	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.
Vascular Reactivity	Pre-Vaping Session at Visit 1	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.

Trial Locations

Locations (1): Ohio State University Comprehensive Cancer Center
🇺🇸
Columbus, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States