Perceptions of Vaping Products

The Ohio State University

Status: Completed

Conditions: Exposure; Abuse Tobacco

Treatments: Other: Biospecimen Collection; Other: Survey Administration; Other: 6-methyl-nicotine (metatine) e-cigarette; Behavioral: Vaping Topography; Other: Participant's Own Preferred E-cigarette; Other: Nicotine E-cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT06868368

OSU-24276

NCI-2024-10267 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 21 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Participant's personal nicotine e-cigarette

Active Comparator group

Description:

The study participant's own preferred e-cigarette will be used for this condition.

Treatment:

Other: Participant's Own Preferred E-cigarette

Behavioral: Vaping Topography

Other: Survey Administration

Other: Biospecimen Collection

Nicotine e-cigarette

Active Comparator group

Description:

A fruit flavored commercially available nicotine e-cigarette will be used for this condition.

Treatment:

Other: Nicotine E-cigarette

Behavioral: Vaping Topography

Other: Survey Administration

Other: Biospecimen Collection

6-methyl nicotine (metatine) e-cigarette

Active Comparator group

Description:

A fruit flavored commercially available metatine e-cigarette will be used for this condition.

Treatment:

Behavioral: Vaping Topography

Other: 6-methyl-nicotine (metatine) e-cigarette

Other: Survey Administration

Other: Biospecimen Collection