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Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

NCT ID: NCT05458895

Last Updated: 2024-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2023-08-07

Brief Summary

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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.

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Detailed Description

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We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.

Conditions

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E-cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

ECIG lab session 1

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 2

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 3

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 4

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 5

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 6

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 7

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

ECIG lab session 8

Intervention Type OTHER

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.

Interventions

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ECIG lab session 1

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.

Intervention Type OTHER

ECIG lab session 2

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.

Intervention Type OTHER

ECIG lab session 3

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.

Intervention Type OTHER

ECIG lab session 4

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.

Intervention Type OTHER

ECIG lab session 5

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.

Intervention Type OTHER

ECIG lab session 6

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.

Intervention Type OTHER

ECIG lab session 7

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.

Intervention Type OTHER

ECIG lab session 8

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A current exclusive e-cigarette user (\>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
* 21-25 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Theodore Wagener

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theodore L Wagener, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Marielle Brinkman, BS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39120901 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2021-06437

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-20313

Identifier Type: -

Identifier Source: org_study_id

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