Cigarette Smoking-Related CarcinomaARISENCT06763536
Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia
A study testing Carbon Monoxide Measurement, Nicotine Lozenge and Oral Nicotine Pouch in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Carbon Monoxide Measurement, Nicotine Lozenge 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
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to 31 Dec 2028
- 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
- Read and speak English
- 21 years or older
- Smoke ≥ 5 cigarettes per day for the past year
- Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)
- Live in a rural Appalachian County
- Have a smartphone and/or willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only)
- Willing to blow air into a handheld study device
- If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results
Who cannot join
- Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
- Use of ONPs in past 3 months
- Use of Nicotine Replacement Therapies in past 3 months
- Use of other tobacco products > 10 days/month
- Unstable or significant medical condition
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
Show all 9Show fewer
- History of cardiac event or distress within the past 3 months
- Live in same household as another study participant.
- Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brittney L. Keller-Hamilton, PhD, MPH, 614-366-9652
Brittney L. Keller-Hamilton
About this study
Official title: Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia
This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT.
II. Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT.
III. Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I:
SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.
ARM II:
SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Carbon Monoxide Measurement, Nicotine Lozenge, Oral Nicotine Pouch, Nicotine Patch, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Monoxide MeasurementOther
Also called Carbon Monoxide, Covita iCOquit
Undergo carbon monoxide measurement
Nicotine LozengeOther
Also called Rugby, Nicotine Replacement Therapy
Use nicotine lozenge
Oral Nicotine PouchOther
Also called ZYN
Use oral nicotine pouch
Nicotine PatchOther
Also called Rugby, Nicotine Skin Patch, Nicotine Transdermal Patch, Nicotine Replacement Therapy
Use nicotine patch
Survey AdministrationOther
measurements; data gathering
Check-in Phone CallsOther
Check-in phone calls to study participants
| Study group | Role | What they receive |
|---|---|---|
| Arm I (oral nicotine pouch) | Experimental | SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends. Receives: Other: Carbon Monoxide Measurement; Other: Oral Nicotine Pouch; Other: Survey Administration; Other: Check-in Phone Calls |
| Arm II (nicotine replacement therapy) | Active comparator | SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends. Receives: Other: Carbon Monoxide Measurement; Other: Nicotine Lozenge; Other: Nicotine Patch; Other: Survey Administration; Other: Check-in Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified 7-day point prevalence abstinence from cigarettes
Statistical analyses will be performed using SAS 9.4. P-values less than 0.05 will be considered statistically significant. Will be presented as frequencies and proportions and compared with chi-squared tests.
Measured: At the end of the 12- week switch phase
Complete switching rate (Aim 1)
Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Measured: At the end of the 12-week switch phase
Abstinence from cigarettes (Aim 1)
Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Measured: At the end of the 12-week switch phase
Cigarettes smoked per day (Aim 1)
If needed, will apply a normalizing transformation to the number of cigarettes smoked per day (e.g., taking the logarithm) before proceeding with the analysis as a means of removing the effects of potential outliers. Will compare cigarettes smoked per day between the two arms using linear regression analysis. The model will adjust for cigarettes smoked per day at baseline and other baseline variables if they are imbalanced.
Measured: At the end of the 12-week switch phase
Differences in product appeal (Aim 2)
Will be adjusted for potential confounders including baseline variables such as age, gender, number of cigarettes smoked per day, and/or randomization stratification factors as necessary; normalizing transformations will be employed if needed.
Measured: From baseline to the end of the 12 week switch phase
Cigarette craving (Aim 2)
Will be evaluated with linear regression models adjusting for appropriate confounders.
Measured: Up to the end of the 12 week switch phase
Withdrawal symptoms (Aim 2)
Will be evaluated with linear regression models adjusting for appropriate confounders.
Measured: Up to the end of the 12 week switch phase
Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2)
Using linear regression analysis, adjusting for baseline nicotine dependence.
Measured: From baseline to the end of the 12 weeks switch phase
Abstinence from cigarettes (Aim 3)
Will be compared between arms using logistic regression analysis and will be evaluated with a logistic regression model.
Measured: Up to the end of the 14 week observation phase
Number of days the study products are used (Aim 3)
Linear regression analysis will be used to compare the number of days the products are used. A normalizing transformation will be employed if needed and appropriate baseline characteristics will be adjusted for.
Measured: Up to the end of the 14 week observation phase
Purchase and continued use of the study products (Aim 3)
Will be compared between the arms with logistic regression analysis, adjusting for all appropriate confounders.
Measured: Up to the end of the 14 week observation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start13 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- 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
- NCT06763536
- Sponsor's protocol ID
- 2024C0064
- Other IDs
- NCI-2024-09181, R01CA289551-01
- Acronym
- ARISE
- Status last verified
- Jun 2026
- First submitted
- 2 Jan 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wermert A, Brasky TM, Newton AM, Hinton A, Curran H, Ferketich AK, Carpenter MJ, Shields PG, Tomko P, Wagener TL, Keller-Hamilton B. Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol. PLoS One. 2025 Dec 23;20(12):e0338503. doi: 10.1371/journal.pone.0338503. eCollection 2025.
PubMed 41433314
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia
- ClinicalTrials.gov ID
- NCT06763536
- Acronym / sponsor ID
- ARISE / 2024C0064
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 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 clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT.
II. Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT.
III. Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I:
SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.
ARM II:
SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks.
SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks.
Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study.
OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (oral nicotine pouch) | Experimental | Other: Carbon Monoxide Measurement, Other: Oral Nicotine Pouch, Other: Survey Administration, Other: Check-in Phone CallsSAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends. |
| Arm II (nicotine replacement therapy) | Active comparator | Other: Carbon Monoxide Measurement, Other: Nicotine Lozenge, Other: Nicotine Patch, Other: Survey Administration, Other: Check-in Phone CallsSAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Read and speak English
- 21 years or older
- Smoke ≥ 5 cigarettes per day for the past year
- Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)
- Live in a rural Appalachian County
Key exclusion criteria (9 listed)
- Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
- Use of ONPs in past 3 months
- Use of Nicotine Replacement Therapies in past 3 months
- Use of other tobacco products > 10 days/month
- Unstable or significant medical condition
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 |
|---|---|---|
| Carbon Monoxide MeasurementAlso: Carbon Monoxide, Covita iCOquitUndergo carbon monoxide measurement | Other | Arm I (oral nicotine pouch), Arm II (nicotine replacement therapy) |
| Nicotine LozengeAlso: Rugby, Nicotine Replacement TherapyUse nicotine lozenge | Other | Arm II (nicotine replacement therapy) |
| Oral Nicotine PouchAlso: ZYNUse oral nicotine pouch | Other | Arm I (oral nicotine pouch) |
| Nicotine PatchAlso: Rugby, Nicotine Skin Patch, Nicotine Transdermal Patch, Nicotine Replacement TherapyUse nicotine patch | Other | Arm II (nicotine replacement therapy) |
| Survey Administrationmeasurements; data gathering | Other | Arm I (oral nicotine pouch), Arm II (nicotine replacement therapy) |
| Check-in Phone CallsCheck-in phone calls to study participants | Other | Arm I (oral nicotine pouch), Arm II (nicotine replacement therapy) |
Primary outcome
Biochemically verified 7-day point prevalence abstinence from cigarettes
Time frame: At the end of the 12- week switch phase
Statistical analyses will be performed using SAS 9.4. P-values less than 0.05 will be considered statistically significant. Will be presented as frequencies and proportions and compared with chi-squared tests.
Complete switching rate (Aim 1)
Time frame: At the end of the 12-week switch phase
Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Abstinence from cigarettes (Aim 1)
Time frame: At the end of the 12-week switch phase
Will be compared between arms using logistic regression analysis, adjusting for baseline variables as needed.
Cigarettes smoked per day (Aim 1)
Time frame: At the end of the 12-week switch phase
If needed, will apply a normalizing transformation to the number of cigarettes smoked per day (e.g., taking the logarithm) before proceeding with the analysis as a means of removing the effects of potential outliers. Will compare cigarettes smoked per day between the two arms using linear regression analysis. The model will adjust for cigarettes smoked per day at baseline and other baseline variables if they are imbalanced.
Differences in product appeal (Aim 2)
Time frame: From baseline to the end of the 12 week switch phase
Will be adjusted for potential confounders including baseline variables such as age, gender, number of cigarettes smoked per day, and/or randomization stratification factors as necessary; normalizing transformations will be employed if needed.
Cigarette craving (Aim 2)
Time frame: Up to the end of the 12 week switch phase
Will be evaluated with linear regression models adjusting for appropriate confounders.
Withdrawal symptoms (Aim 2)
Time frame: Up to the end of the 12 week switch phase
Will be evaluated with linear regression models adjusting for appropriate confounders.
Change in nicotine dependence among participants who completely switched to their assigned study product (Aim 2)
Time frame: From baseline to the end of the 12 weeks switch phase
Using linear regression analysis, adjusting for baseline nicotine dependence.
Abstinence from cigarettes (Aim 3)
Time frame: Up to the end of the 14 week observation phase
Will be compared between arms using logistic regression analysis and will be evaluated with a logistic regression model.
Number of days the study products are used (Aim 3)
Time frame: Up to the end of the 14 week observation phase
Linear regression analysis will be used to compare the number of days the products are used. A normalizing transformation will be employed if needed and appropriate baseline characteristics will be adjusted for.
Purchase and continued use of the study products (Aim 3)
Time frame: Up to the end of the 14 week observation phase
Will be compared between the arms with logistic regression analysis, adjusting for all appropriate confounders.
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 30 Jun 2026.
- Derived from this study: PubMed 41433314Wermert A, Brasky TM, Newton AM, Hinton A, Curran H, Ferketich AK, Carpenter MJ, Shields PG, Tomko P, Wagener TL, Keller-Hamilton B. Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol. PLoS One. 2025 Dec 23;20(12):e0338503. doi: 10.1371/journal.pone.0338503. eCollection 2025.
- The JameslineLink provided by the sponsor.
Related trials for Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Not yet recruiting
A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial
Cigarette Smoking-Related Carcinoma
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
RecruitingPhase 4
Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
Cigarette Smoking-Related Carcinoma
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.
The Ohio State University Comprehensive Cancer Center contact
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 study testing Carbon Monoxide Measurement, Nicotine Lozenge and Oral Nicotine Pouch in people with Cigarette Smoking-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 8 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 30 Jun 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 The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified 7-day point prevalence abstinence from cigarettes (time frame: At the end of the 12- week switch phase). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763536, which also lists 1 linked publication.
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 30 Jun 2026.