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

Not Applicable

Completed

• Conditions: Tobacco Smoking; Tobacco Use; Cigarette Smoking; Smokeless Tobacco Cessation
• Interventions: Other: Electronic Cigarette; Other: Oral Nicotine Pouch

• Registration Number: NCT05030194
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-01
• Study Start: 2021-10-21
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes	Electronic Cigarette	Participants will use each product for up to a 30 minute interval But will also be permitted to stop use before the end of the 30-minute ad lib use period
Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes	Oral Nicotine Pouch	Participants will use each product for up to a 30 minute interval But will also be permitted to stop use before the end of the 30-minute ad lib use period
Order 2 - Electronic Cigarettes and Oral Nicotine product	Electronic Cigarette	Participants will use each prodcut for up to 30 minutes but will also be permitted to stop use before the end of the 30-minute ad lib use period
Order 2 - Electronic Cigarettes and Oral Nicotine product	Oral Nicotine Pouch	Participants will use each prodcut for up to 30 minutes but will also be permitted to stop use before the end of the 30-minute ad lib use period

Primary Outcome Measures

Name	Time	Method
Change in sensory response	up to 1 year	will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely).
Change in nicotine boost	up to week 4	will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration

Secondary Outcome Measures

Name	Time	Method
Change is stress markers	Up to 4 weeks	Saliva will be collected before and after product use of each product to establish plasma nicotine concentrations

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States