Clinical trial NCT06868368: Perceptions of Vaping Products
Official title: Perceptions of Vaping Products Among Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abuse Tobacco
Exposure
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization to condition order will be completed prior to study Visit 1. Each participant will receive a randomized ordering developed using a random sequence generator.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of metatine and nicotine e-cigarettes
timeFrame: Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session
measure: E-cigarette puffing behavior
timeFrame: 30 minute vaping session
measure: Sensory perceptions of EC vaping experience
timeFrame: Minute 5 of vaping session, Minute 30 of vaping session
measure: Appeal and Sensory
timeFrame: Minute 5 of vaping session, Minute 30 of vaping session
measure: Relief of withdrawal symptoms
timeFrame: Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session
Secondary outcomes:
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: Alayna P Tackett, PhD
role: PRINCIPAL_INVESTIGATOR
References: