Smokeless TobaccoNCT07107139
Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
A study testing Copenhagen group and Snus group in people with Smokeless Tobacco, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco
- What is being tested?
- Copenhagen group and Snus group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years of age
- Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- Open to trying a non-combusted oral tobacco product
- Have the ability to read, write, and communicate in English
- Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus > $0
Show all 9Show fewer
- Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (<8ppm)
- Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.
- 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 procedure.
Who cannot join
- Age ≥ 21 years of age
- Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- Open to trying a non-combusted oral tobacco product
- Have the ability to read, write, and communicate in English
- Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus > $0
Show all 9Show fewer
- Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (<8ppm) .
- Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.
- 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 procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park
Buffalo, New York, 14263
ask rpci, 877-275-7724, askrpci@roswellpark.org
Richard O'Connor, PHD
About this study
This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.
- Conditions
- Smokeless Tobacco
- Being tested
- Copenhagen group, Snus group
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copenhagen groupOther
Participants use product for up to 30 minutes
Snus groupOther
Participants use product for up to 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Copenhagen group | Active comparator | Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes. Receives: Other: Copenhagen group |
| Snus Group | Active comparator | Participants will place one pouch of snus beween cheek and gums for up to 30 minutes. Receives: Other: Snus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sensory response
assessed with a 0-100 visual analog scale - anchored by word descriptors at each end.
Measured: Before viewing study ads and immediatley after viewing
Secondary outcomes (1)
Change in nicotine boost
Will be measured after use of products with gas chromatography-mass spectrometry
Measured: Will be collected after 5, 15 and 30 minutes of product use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start11 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokeless TobaccoStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107139
- Sponsor's protocol ID
- I-4008824-1
- Other IDs
- R21CA289541
- Status last verified
- May 2026
- First submitted
- 30 Jul 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
- ClinicalTrials.gov ID
- NCT07107139
- Acronym / sponsor ID
- I-4008824-1
- Conditions
- Smokeless Tobacco
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copenhagen group | Active comparator | Other: Copenhagen groupParticipants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes. |
| Snus Group | Active comparator | Other: Snus groupParticipants will place one pouch of snus beween cheek and gums for up to 30 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 21 years of age
- Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- Open to trying a non-combusted oral tobacco product
- Have the ability to read, write, and communicate in English
Key exclusion criteria (9 listed)
- Age ≥ 21 years of age
- Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- Open to trying a non-combusted oral tobacco product
- Have the ability to read, write, and communicate in English
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 |
|---|---|---|
| Copenhagen groupParticipants use product for up to 30 minutes | Other | Copenhagen group |
| Snus groupParticipants use product for up to 30 minutes | Other | Snus Group |
Primary outcome
Change in sensory response
Time frame: Before viewing study ads and immediatley after viewing
assessed with a 0-100 visual analog scale - anchored by word descriptors at each end.
1 secondary outcome
Change in nicotine boost
Time frame: Will be collected after 5, 15 and 30 minutes of product use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copenhagen group and Snus group in people with Smokeless Tobacco, 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 9 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK RPCI (1-877-275-7724, askrpci@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sensory response (time frame: Before viewing study ads and immediatley after viewing). 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 22 May 2026.