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

NCT05030194 | Completed

• 1 other identifier: I 1574221
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change is stress markers

  Up to 4 weeks

Study Arms (2)

Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes

EXPERIMENTAL

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; Other: Oral Nicotine Pouch

Order 2 - Electronic Cigarettes and Oral Nicotine product

EXPERIMENTAL

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; Other: Oral Nicotine Pouch

Interventions

Electronic Cigarette 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.

Also known as: Vuse Alto

Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes; Order 2 - Electronic Cigarettes and Oral Nicotine product

Oral Nicotine Pouch OTHER

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

Also known as: ZYN

Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes; Order 2 - Electronic Cigarettes and Oral Nicotine product

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current daily cigarette smoker as determined by:
• Smokes \>5 cigarettes/day for \>1 year OR
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

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

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior; Smoking; Health Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Maciej Goniewicz, PhD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: October 21, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)