Perceptions of Vaping Products

Not Applicable

Recruiting

• Conditions: Abuse Tobacco; Exposure

• Registration Number: NCT06868368
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.

Detailed Description

PRIMARY OBJECTIVES:

I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.

II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.

III. Determine the impact of metatine on e-cigarette puffing behavior (topography).

OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.

Study Timeline

• Study First Submitted: 2025-01-14
• Status Verified: 2025-03
• Study Start: 2025-03-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 21-34 years
• Current nicotine EC user (defined as ≥ weekly use over the past 3 months)
• Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions
• Read and speak English

Exclusion Criteria

• Recently coronavirus disease 2019 (COVID-19) positive (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)
• Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• History of cardiac event or distress within the past 3 months
• Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days
• Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
• Have hemophilia or another type of bleeding disorder
• Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of metatine and nicotine e-cigarettes	Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session	Pharmacokinetics of metatine and nicotine e-cigarettes will be examined by measuring the concentration of metatine and nicotine in blood plasma at different timepoints throughout the study vaping session.
E-cigarette puffing behavior	30 minute vaping session	E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.
Sensory perceptions of EC vaping experience	Minute 5 of vaping session, Minute 30 of vaping session	Sensory perceptions of vaping will be measured by the Sensory E-cigarette Expectancies Scale (SEES) questionnaire. The SEES asks questions about sensory experiences associated with vaping on a scale from 0 (Never) - 4 (Almost Always).
Appeal and Sensory	Minute 5 of vaping session, Minute 30 of vaping session	Participants will rate appeal (e.g., liking, disliking) and sensory attributes (e.g., harshness, coolness) outcomes on Visual Analogue Scales (range, 0-100).
Relief of withdrawal symptoms	Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session	Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None, Slight, Moderate, Mild, or Severe.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States