Purpose

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

Conditions

Eligibility

Eligible Ages
Between 21 Years and 34 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
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
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Participant's personal nicotine e-cigarette
The study participant's own preferred e-cigarette will be used for this condition.
  • Other: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
  • Other: Survey Administration
    Complete Surveys
  • Behavioral: Vaping Topography
    Use e-cigarette connected to a topography device
  • Other: Participant's Own Preferred E-cigarette
    Participant vapes their own preferred e-cigarette for 30 minutes
Active Comparator
Nicotine e-cigarette
A fruit flavored commercially available nicotine e-cigarette will be used for this condition.
  • Other: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
  • Other: Survey Administration
    Complete Surveys
  • Behavioral: Vaping Topography
    Use e-cigarette connected to a topography device
  • Other: Nicotine E-cigarette
    Participant vapes a commercially available nicotine e-cigarette for 30 minutes
Active Comparator
6-methyl nicotine (metatine) e-cigarette
A fruit flavored commercially available metatine e-cigarette will be used for this condition.
  • Other: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
  • Other: Survey Administration
    Complete Surveys
  • Behavioral: Vaping Topography
    Use e-cigarette connected to a topography device
  • Other: 6-methyl-nicotine (metatine) e-cigarette
    Participant vapes a commercially available metatine e-cigarette for 30 minutes

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Alayna P. Tackett, PhD
Alyana.Tackett@osumc.edu

More Details

NCT ID
NCT06868368
Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.