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

NCT ID: NCT05030194

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-21
• Study Completion Date: 2023-01-25

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.

Conditions

Tobacco Use; Tobacco Smoking; Cigarette Smoking; Smokeless Tobacco Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes

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

Group Type: EXPERIMENTAL

Electronic Cigarette

Intervention Type: OTHER

Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.

Oral Nicotine Pouch

Intervention Type: OTHER

Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.

Order 2 - Electronic Cigarettes and Oral Nicotine product

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

Group Type: EXPERIMENTAL

Electronic Cigarette

Intervention Type: OTHER

Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.

Oral Nicotine Pouch

Intervention Type: OTHER

Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.

Interventions

Electronic Cigarette

Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.

Intervention Type: OTHER

Oral Nicotine Pouch

Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.

Intervention Type: OTHER

Other Intervention Names

Vuse Alto; ZYN

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maciej Goniewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Comprehensive Cancer Center

Locations

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Countries

United States

Other Identifiers

I 1574221

Identifier Type: -

Identifier Source: org_study_id