Tobacco-Related CarcinomaEarly Phase 1NCT05730439
Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
A Early Phase 1 study testing Biospecimen Collection, Nicotine Oral Pouch and Questionnaire Administration in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Nicotine Oral Pouch and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 5 Aug 2024
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Reside in an Ohio Appalachian county or surrounding rural area
- Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
- Ability to read and speak English
- Daily use of smokeless tobacco for the past 3 months
Who cannot join
- Use tobacco products other than smokeless tobacco > 10 days per month
- Unstable or significant psychiatric conditions for > 1 year (past and stable conditions will be allowed)
- Pregnant, planning to become pregnant, or breastfeeding
- History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year
- Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months
- Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess appeal, perceived substitutability, and nicotine delivery of nicotine pouches (NPs) with high versus (vs.) low free-base nicotine (FBN) content among rural and Appalachian moist snuff users.
II. Evaluate whether smokeless tobacco (SLT) dependence modifies effects of NP FBN content on product appeal, perceived substitutability, and nicotine delivery.
OUTLINE: Participants are randomized to 1 of 6 arms.
ARM I: Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine pouch at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo intravenous (IV) line insertion and collection of blood on study.
ARM II: Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine pouch at study visit 2, and ZYN brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM III: Participants receive ZYN brand nicotine pouch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM IV: Participants receive ZYN brand nicotine pouch at study visit 1, Rogue brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM V: Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM VI: Participants receive Rogue brand nicotine pouch at study visit 1, ZYN brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Biospecimen Collection, Nicotine Oral Pouch, Questionnaire Administration, Smokeless Tobacco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood
Nicotine Oral PouchDrug
Also called ZYN
Receive ZYN brand NP
Nicotine Oral PouchDrug
Also called Rogue
Receive Rogue brand NP
Questionnaire AdministrationOther
Ancillary studies
Smokeless TobaccoDrug
Also called Smoking, Tobacco and Cancer - Smokeless Tobacco
Receive usual SLT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual SLT, ZYN NP, Rogue NP) | Experimental | Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
| Arm II (usual SLT, Rogue NP, ZYN NP) | Experimental | Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
| Arm III (ZYN NP, usual SLT, Rogue NP) | Experimental | Participants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
| Arm IV (ZYN NP, Rogue NP, usual SLT) | Experimental | Participants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
| Arm V (Rogue NP, usual SLT, ZYN NP) | Experimental | Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
| Arm VI (Rogue NP, ZYN NP, usual SLT) | Experimental | Participants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smokeless Tobacco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine delivery (Aim 1)
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess the effects of product type on plasma nicotine delivery. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Measured: From baseline to study completion, assessed up to 2 years
Behavioral intentions (Aim 1)
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess behavioral intentions with regard to nicotine pouches (NPs). Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Measured: From baseline to study completion, assessed up to 2 years
Baseline characteristics (Aim 1)
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Measured: From baseline to study completion, assessed up to 2 years
Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)
Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type on behavioral intentions. Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Measured: From baseline to study completion, assessed up to 2 years
Smokeless tobacco (SLT) dependence effects on NP free-base nicotine (FBN) content on product appeal (Aim 2)
Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type between the two-level indicator for SLT dependence (low/moderate vs. high). Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Measured: From baseline to study completion, assessed up to 2 years
Secondary outcomes (1)
ONP and Smokeless Tobacco Purchase Task (Aims 1 and 2)
Data will be used to assess the prices participants would be willing to pay for each unit of product. Using demand curves generated from self-report data for each product, we will be able to determine how participants' usual brand of SLT compares to ONPs at different price points.
Measured: From baseline to study completion, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start19 May 2023
- Primary completion30 Jan 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittney Keller-Hamilton, Ohio State University Comprehensive Cancer Center
- Investigators
- Brittney L Keller-Hamilton, PhD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730439
- Sponsor's protocol ID
- OSU-22197
- Other IDs
- NCI-2023-00134
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
- ClinicalTrials.gov ID
- NCT05730439
- Acronym / sponsor ID
- OSU-22197
- Conditions
- Tobacco-Related Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 15 Feb 2023 (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 clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.
Detailed description
PRIMARY OBJECTIVES:
- Assess appeal, perceived substitutability, and nicotine delivery of nicotine pouches (NPs) with high versus (vs.) low free-base nicotine (FBN) content among rural and Appalachian moist snuff users.
II. Evaluate whether smokeless tobacco (SLT) dependence modifies effects of NP FBN content on product appeal, perceived substitutability, and nicotine delivery.
OUTLINE: Participants are randomized to 1 of 6 arms.
ARM I: Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine pouch at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo intravenous (IV) line insertion and collection of blood on study.
ARM II: Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine pouch at study visit 2, and ZYN brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM III: Participants receive ZYN brand nicotine pouch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM IV: Participants receive ZYN brand nicotine pouch at study visit 1, Rogue brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM V: Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
ARM VI: Participants receive Rogue brand nicotine pouch at study visit 1, ZYN brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual SLT, ZYN NP, Rogue NP) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. |
| Arm II (usual SLT, Rogue NP, ZYN NP) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. |
| Arm III (ZYN NP, usual SLT, Rogue NP) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. |
| Arm IV (ZYN NP, Rogue NP, usual SLT) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study. |
| Arm V (Rogue NP, usual SLT, ZYN NP) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study. |
| Arm VI (Rogue NP, ZYN NP, usual SLT) | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Questionnaire Administration, Drug: Smokeless TobaccoParticipants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or older
- Reside in an Ohio Appalachian county or surrounding rural area
- Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
- Ability to read and speak English
- Daily use of smokeless tobacco for the past 3 months
Key exclusion criteria (6 listed)
- Use tobacco products other than smokeless tobacco > 10 days per month
- Unstable or significant psychiatric conditions for > 1 year (past and stable conditions will be allowed)
- Pregnant, planning to become pregnant, or breastfeeding
- History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year
- Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood | Procedure or surgery | Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT) |
| Nicotine Oral PouchAlso: ZYNReceive ZYN brand NP | Drug | Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT) |
| Nicotine Oral PouchAlso: RogueReceive Rogue brand NP | Drug | Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT) |
| Smokeless TobaccoAlso: Smoking, Tobacco and Cancer - Smokeless TobaccoReceive usual SLT | Drug | Arm I (usual SLT, ZYN NP, Rogue NP), Arm II (usual SLT, Rogue NP, ZYN NP), Arm III (ZYN NP, usual SLT, Rogue NP), Arm IV (ZYN NP, Rogue NP, usual SLT), Arm V (Rogue NP, usual SLT, ZYN NP), Arm VI (Rogue NP, ZYN NP, usual SLT) |
Primary outcome
Plasma nicotine delivery (Aim 1)
Time frame: From baseline to study completion, assessed up to 2 years
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess the effects of product type on plasma nicotine delivery. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Behavioral intentions (Aim 1)
Time frame: From baseline to study completion, assessed up to 2 years
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess behavioral intentions with regard to nicotine pouches (NPs). Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Baseline characteristics (Aim 1)
Time frame: From baseline to study completion, assessed up to 2 years
Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)
Time frame: From baseline to study completion, assessed up to 2 years
Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type on behavioral intentions. Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
Smokeless tobacco (SLT) dependence effects on NP free-base nicotine (FBN) content on product appeal (Aim 2)
Time frame: From baseline to study completion, assessed up to 2 years
Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type between the two-level indicator for SLT dependence (low/moderate vs. high). Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.
1 secondary outcome
ONP and Smokeless Tobacco Purchase Task (Aims 1 and 2)
Time frame: From baseline to study completion, assessed up to 2 years
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 27 Apr 2026.
- The JameslineLink provided by the sponsor.
- 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.
Brittney L Keller-Hamilton, PhD, MPH principal investigator
Ohio State University 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 Early Phase 1 study testing Biospecimen Collection, Nicotine Oral Pouch and Questionnaire Administration in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 6 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 27 Apr 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma nicotine delivery (Aim 1) (time frame: From baseline to study completion, assessed up to 2 years). The study lists 5 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 27 Apr 2026.