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Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study] | Clinical Trials | Clareo Health

COMPLETEDNA

Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

NCT05030194•Roswell Park Cancer Institute

View on ClinicalTrials.gov

Summary

To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.

Detailed Description

This study will assess the use, nicotine delivery, subjective response, and sensory appeal of an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.

Eligibility

Age

21 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Current daily cigarette smoker as determined by:
•1. Smokes \>5 cigarettes/day for \>1 year OR
•2. Current daily smokeless tobacco or oral nicotine user as determined by:
•a. Uses \>=5 units/day for \>=1 year
•b. Uses portioned moist snuff, loose moist snuff and/or nicotine patches
•Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide \< 10ppm).
•Self-report fair or better physical health.
•Self-report fair or better mental health.
•Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related products

Exclusion Criteria

•Currently uses other tobacco or nicotine products (e.g., ENDS) \> 2 days/week.
•Self-report having active, untreated medical/psychiatric conditions History of serious side effects from nicotine or from any nicotine replacement therapies.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Nursing female participants.
•Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
•Unwilling or unable to follow protocol requirements.
•Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
•Previous use of the study products (ZYN or Vuse Alto; on! or General Slims).

Locations (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Key Dates

Start Date

October 21, 2021

Primary Completion Date

January 25, 2023

Completion Date

January 25, 2023

Last Updated

October 26, 2023

Enrollment

ACTUAL participants

Conditions

Tobacco UseTobacco SmokingCigarette SmokingSmokeless Tobacco Cessation

Interventions

Electronic Cigarette

OTHER

Oral Nicotine Pouch

OTHER

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

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E-cigarette UseCigarette Smoking+2 more

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RECRUITINGNA

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

Inclusion Criteria

Exclusion Criteria

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences

Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chronic Pain

Buteyko Breathing and Approach of Smoking Hygiene: Effects on Dysfucntion of Eustachian Tube and Lung Functions

E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness