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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Tobacco Smoking; Cigarette Smoking; Smokeless Tobacco Cessation
• Intervention / Treatment: Other: Electronic Cigarette; Other: Oral Nicotine Pouch

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Vuse Alto; 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.; Other Names: ZYN
Experimental: 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	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.; Other Names: Vuse Alto; 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.; Other Names: ZYN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Maciej Goniewicz, PhD, Roswell Park Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: I 1574221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No