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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Cigarette Smoking; Tobacco Smoking; Tobacco Use; Smokeless Tobacco Cessation

Treatments: Other: Electronic Cigarette; Other: Oral Nicotine Pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT05030194

I 1574221

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes

Experimental group

Description:

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

Treatment:

Other: Oral Nicotine Pouch

Other: Electronic Cigarette

Order 2 - Electronic Cigarettes and Oral Nicotine product

Experimental group

Description:

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

Treatment:

Other: Oral Nicotine Pouch

Other: Electronic Cigarette