NCT06763536 · Ohio State University Comprehensive Cancer Center
Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia
(ARISE)
What this study is about
This clinical trial compares the use of taken by mouth 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 taken by mouth cancers that plague Appalachia are fueled by cigarette smoking.
View original scientific description
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.
Interventions
OTHER
Carbon Monoxide Measurement
Undergo carbon monoxide measurement
OTHER
Nicotine Lozenge
Use nicotine lozenge
OTHER
Oral Nicotine Pouch
Use oral nicotine pouch
OTHER
Nicotine Patch
Use nicotine patch
OTHER
Survey Administration
measurements; data gathering
OTHER
Check-in Phone Calls
Check-in phone calls to study participants
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
- 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
Where
- Columbus, Ohio
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations