Clinical trial NCT05458895: Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
Official title: Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-cigarette Use
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Nicotine Concentration
timeFrame: 0, 5, 10, 35 min.
measure: Puff Count
timeFrame: 30 minutes
measure: Average Puff Duration
timeFrame: 30 minutes
measure: Average Puff Volume
timeFrame: 30 minutes
measure: Lung Function Assessment
timeFrame: Baseline and 35 minutes
measure: Airway Inflammation (NIOX VERO)
timeFrame: 35 minutes
Secondary outcomes:
measure: Sensory E-Cigarette Expectancies Scale (SEES)
timeFrame: Baseline
measure: Modified Cigarette Dependence Scale
timeFrame: Baseline
measure: Drug Effects/Liking Questionnaire
timeFrame: 35 minutes
measure: Modified Cigarette Evaluation Questionnaire (mCEQ)
timeFrame: 35 minutes
measure: E-cigarette Purchase Task - Breakpoint
timeFrame: 35 minutes
measure: Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form
timeFrame: 0, 5, 10, 35 min.
measure: Vascular Reactivity
timeFrame: Pre-Vaping Session at Visit 1
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Theodore L Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Marielle Brinkman, BS
role: PRINCIPAL_INVESTIGATOR
References: