Tobacco UseNCT06568900
Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period
A study testing cigarette smoking, tobacco flavored and unflavored pouch and unrestricted flavor options pouch in people with Tobacco Use, run by Swedish Match AB at 1 site in United States.
Trial summary
To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- cigarette smoking, tobacco flavored and unflavored pouch and unrestricted flavor options pouch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 19 Aug 2024
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
- Interested in switching from combustible cigarettes to nicotine pouch products.
Who cannot join
- Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
- Participants who currently use nicotine pouches.
- Participants with known heart disease or medical condition that may adversely affect participant safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and Biomarkers of Exposure in Adult Smokers Over a 12-week Period
To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.
Read the detailed description
US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.
- Conditions
- Tobacco Use
- Being tested
- cigarette smoking, tobacco flavored and unflavored pouch, unrestricted flavor options pouch
- Keywords
- nicotine, tobacco, nicotine containing products
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cigarette smokingOther
continue smoking usual brand of cigarette
tobacco flavored and unflavored pouchOther
provide tobacco flavored and unflavored options of nicotine pouch
unrestricted flavor options pouchOther
provide unrestricted flavor options of nicotine pouch
| Study group | Role | What they receive |
|---|---|---|
| (control) continue smoking their usual brand of CC | Active comparator | Not described Receives: Other: cigarette smoking |
| tobacco flavor and unflavored options of ZYN | Active comparator | Not described Receives: Other: tobacco flavored and unflavored pouch |
| unrestricted flavor options of ZYN | Active comparator | Not described Receives: Other: unrestricted flavor options pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
Measured: Measured from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start31 Jul 2023
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Match AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian E Erkkila, PhD, Study chair, Swedish Match
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568900
- Sponsor's protocol ID
- Pro00070188
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and Biomarkers of Exposure in Adult Smokers Over a 12-week Period
- ClinicalTrials.gov ID
- NCT06568900
- Acronym / sponsor ID
- Pro00070188
- Conditions
- Tobacco Use
- Keywords
- nicotine, tobacco, nicotine containing products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Swedish Match ABIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 23 Aug 2024 (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 verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.
Detailed description
US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (control) continue smoking their usual brand of CC | Active comparator | Other: cigarette smoking |
| tobacco flavor and unflavored options of ZYN | Active comparator | Other: tobacco flavored and unflavored pouch |
| unrestricted flavor options of ZYN | Active comparator | Other: unrestricted flavor options pouch |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
- Interested in switching from combustible cigarettes to nicotine pouch products.
Key exclusion criteria (3 listed)
- Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
- Participants who currently use nicotine pouches.
- Participants with known heart disease or medical condition that may adversely affect participant safety
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 |
|---|---|---|
| cigarette smokingcontinue smoking usual brand of cigarette | Other | (control) continue smoking their usual brand of CC |
| tobacco flavored and unflavored pouchprovide tobacco flavored and unflavored options of nicotine pouch | Other | tobacco flavor and unflavored options of ZYN |
| unrestricted flavor options pouchprovide unrestricted flavor options of nicotine pouch | Other | unrestricted flavor options of ZYN |
Primary outcome
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine
Time frame: Measured from baseline to week 12
Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
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 23 Aug 2024.
- 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.
Brian E Erkkila, PhD study chair
Swedish Match
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cigarette smoking, tobacco flavored and unflavored pouch and unrestricted flavor options pouch in people with Tobacco Use, run by Swedish Match AB 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 3 inclusion and 3 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 23 Aug 2024. 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?
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine (time frame: Measured from baseline to week 12). 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 23 Aug 2024.