NCT05458895

Brief Summary

This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

September 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 20, 2021

Results QC Date

May 21, 2024

Last Update Submit

September 30, 2024

Conditions

E-cigarette Use

Outcome Measures

Primary Outcomes (6)

  • Plasma Nicotine Concentration

    Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.

    0, 5, 10, 35 min.

  • Puff Count

    E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.

    30 minutes

  • Average Puff Duration

    E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.

    30 minutes

  • Average Puff Volume

    E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.

    30 minutes

  • Lung Function Assessment

    Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)

    Baseline and 35 minutes

  • Airway Inflammation (NIOX VERO)

    Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.

    35 minutes

Secondary Outcomes (7)

  • Sensory E-Cigarette Expectancies Scale (SEES)

    Baseline

  • Modified Cigarette Dependence Scale

    Baseline

  • Drug Effects/Liking Questionnaire

    35 minutes

  • Modified Cigarette Evaluation Questionnaire (mCEQ)

    35 minutes

  • E-cigarette Purchase Task - Breakpoint

    35 minutes

  • +2 more secondary outcomes

Study Arms (8)

High concentration free-base nicotine (5%), Tobacco flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 1

High concentration nicotine salt (5%), Tobacco flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 2

High concentration free-base nicotine (5%), Menthol flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 3

High concentration nicotine salt (5%), Menthol flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 4

Low concentration free-base nicotine (1%), Tobacco flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 5

Low concentration nicotine salt (1%), Tobacco flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 6

Low concentration free-base nicotine (1%), Menthol flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 7

Low concentration nicotine salt (1%), Menthol flavor

EXPERIMENTAL

Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Other: ECIG lab session 8

Interventions

ECIG lab session 1OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

High concentration free-base nicotine (5%), Tobacco flavor
ECIG lab session 2OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

High concentration nicotine salt (5%), Tobacco flavor
ECIG lab session 3OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

High concentration free-base nicotine (5%), Menthol flavor
ECIG lab session 4OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

High concentration nicotine salt (5%), Menthol flavor
ECIG lab session 5OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Low concentration free-base nicotine (1%), Tobacco flavor
ECIG lab session 6OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Low concentration nicotine salt (1%), Tobacco flavor
ECIG lab session 7OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Low concentration free-base nicotine (1%), Menthol flavor
ECIG lab session 8OTHER

vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.

Low concentration nicotine salt (1%), Menthol flavor

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A current exclusive e-cigarette user (\>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
  • years old
  • Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
  • Willing to complete five, 6 hour lab visits
  • Able to read and speak English
  • Willing to provide informed consent

You may not qualify if:

  • Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
  • Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
  • Use of other tobacco products \> 5 days in the past month
  • Current marijuana use \> 5 times per month
  • Currently engaging in a vaping cessation attempt
  • Ohio State University (OSU) verifies study project 2 current membership/past participation

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 Publications (1)

  • Cho YJ, Mehta T, Hinton A, Sloan R, Nshimiyimana J, Tackett AP, Roberts ME, Brinkman MC, Wagener TL. E-Cigarette Nicotine Delivery Among Young Adults by Nicotine Form, Concentration, and Flavor: A Crossover Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426702. doi: 10.1001/jamanetworkopen.2024.26702.

    PMID: 39120901DERIVED

Related Links

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Results Point of Contact

Title
Dr. Theodore L. Wagener
Organization
OhioSUCCC
Theodore.Wagener@osumc.edu
614-366-4265

Study Officials

  • Theodore L Wagener, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Marielle Brinkman, BS

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2021

First Posted

July 14, 2022

Study Start

December 2, 2021

Primary Completion

August 7, 2023

Study Completion

August 7, 2023

Last Updated

November 22, 2024

Results First Posted

November 22, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)