NCT06868368

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
Last Updated

December 22, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

January 14, 2025

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Pharmacokinetics of metatine and nicotine e-cigarettes

    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.

    Pre-vaping session, Minute 5 of vaping session, Minute 15 of vaping session, Minute 30 of vaping session

  • E-cigarette puffing behavior

    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.

    Week 1, Week 2, Week 3

  • Sensory perceptions of EC vaping experience

    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).

    Minute 5 of vaping session, Minute 30 of vaping session

  • Appeal ratings

    Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100).

    Minute 5 of vaping session, Minute 30 of vaping session

  • Sensory ratings

    Participants will rate sensory attributes (e.g., harshness, coolness) on Visual Analogue Scales (range, 0-100).

    Minute 5 of vaping session, Minute 30 of vaping session

  • Relief of withdrawal symptoms

    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.

    Pre-vaping session, Minute 5 of Vaping Session, Minute 30 of vaping session

Study Arms (3)

Participant's personal nicotine e-cigarette

ACTIVE COMPARATOR

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

Other: Biospecimen CollectionOther: Survey AdministrationBehavioral: Vaping TopographyOther: Participant's Own Preferred E-cigarette

Nicotine e-cigarette

ACTIVE COMPARATOR

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

Other: Biospecimen CollectionOther: Survey AdministrationBehavioral: Vaping TopographyOther: Nicotine E-cigarette

6-methyl nicotine (metatine) e-cigarette

ACTIVE COMPARATOR

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

Other: Biospecimen CollectionOther: Survey AdministrationBehavioral: Vaping TopographyOther: 6-methyl-nicotine (metatine) e-cigarette

Interventions

Undergo blood sample collection

Also known as: Biological Sample Collection
6-methyl nicotine (metatine) e-cigaretteNicotine e-cigaretteParticipant's personal nicotine e-cigarette

Complete Surveys

6-methyl nicotine (metatine) e-cigaretteNicotine e-cigaretteParticipant's personal nicotine e-cigarette

Use e-cigarette connected to a topography device

6-methyl nicotine (metatine) e-cigaretteNicotine e-cigaretteParticipant's personal nicotine e-cigarette

Participant vapes their own preferred e-cigarette for 30 minutes

Participant's personal nicotine e-cigarette

Participant vapes a commercially available nicotine e-cigarette for 30 minutes

Nicotine e-cigarette

Participant vapes a commercially available metatine e-cigarette for 30 minutes

6-methyl nicotine (metatine) e-cigarette

Eligibility Criteria

Age21 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alayna P Tackett, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2025

First Posted

March 10, 2025

Study Start

March 3, 2025

Primary Completion

November 4, 2025

Study Completion

November 4, 2025

Last Updated

December 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations