Clinical trial NCT05030194: Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
Official title: Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Tobacco Smoking
Cigarette Smoking
Smokeless Tobacco Cessation
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in nicotine boost
timeFrame: up to week 4
measure: Change in sensory response
timeFrame: up to 1 year
Secondary outcomes:
measure: Change is stress markers
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Maciej Goniewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: