Tobacco UseNCT05030194
Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
A study testing Electronic Cigarette and Oral Nicotine Pouch in people with Tobacco Use and Tobacco Smoking, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Cigarette Smoking
- What is being tested?
- Electronic Cigarette and Oral Nicotine Pouch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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).
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.
Read the 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.
- Being tested
- Electronic Cigarette, Oral Nicotine Pouch
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Cigarette Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic CigaretteOther
Also called Vuse Alto
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.
Oral Nicotine PouchOther
Also called ZYN
Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Electronic Cigarette; Other: Oral Nicotine Pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nicotine boost
will be measured as the post bout plasma nicotine concentration minus the pre-bout plasma nicotine concentration
Measured: 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).
Measured: up to 1 year
Secondary outcomes (1)
Change is stress markers
Saliva will be collected before and after product use of each product to establish plasma nicotine concentrations
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start21 Oct 2021
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Goniewicz, PhD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030194
- Sponsor's protocol ID
- I 1574221
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
- ClinicalTrials.gov ID
- NCT05030194
- Acronym / sponsor ID
- I 1574221
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes | Experimental | Other: Electronic Cigarette, Other: Oral Nicotine PouchParticipants 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 |
| Order 2 - Electronic Cigarettes and Oral Nicotine product | Experimental | Other: Electronic Cigarette, Other: Oral Nicotine PouchParticipants 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Current daily cigarette smoker as determined by:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic CigaretteAlso: Vuse AltoParticipants 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 | Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes, Order 2 - Electronic Cigarettes and Oral Nicotine product |
| Oral Nicotine PouchAlso: ZYNParticipants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes. | Other | Order 1 - Oral Nicotine product - ZYN and Electronic Cigarettes, Order 2 - Electronic Cigarettes and Oral Nicotine product |
Primary outcome
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
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).
1 secondary outcome
Change is stress markers
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Goniewicz, PhD principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Cigarette and Oral Nicotine Pouch in people with Tobacco Use and Tobacco Smoking, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nicotine boost (time frame: up to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.