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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030194
• Other study ID #: I 1574221
• Status: Completed
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: October 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cigarette Smoking
• Smokeless Tobacco Cessation
• Tobacco Smoking
• Tobacco Use

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nicotine boost	will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration	up to week 4
Primary	Change in sensory response	will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely).	up to 1 year
Secondary	Change is stress markers	Saliva will be collected before and after product use of each product to establish plasma nicotine concentrations	Up to 4 weeks