Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in sensory response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
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).
Arms & Interventions
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
Intervention: Electronic Cigarette (Other)
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
Intervention: Oral Nicotine Pouch (Other)
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
Intervention: Electronic Cigarette (Other)
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
Intervention: Oral Nicotine Pouch (Other)
Outcomes
Primary Outcomes
Change in sensory response
Time Frame: up to 1 year
will be measured by a Questionnaire scored on a 0-100 visual analog scale with 0 (Not at all) to 100 (Extremely).
Change in nicotine boost
Time Frame: up to week 4
will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration
Secondary Outcomes
- Change is stress markers(Up to 4 weeks)