Actively Recruiting
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-04-27
160
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate oral nicotine pouches (ONPs) to see if they can be a comparable substitute to cigarettes or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are considered lower risk than combustible cigarettes by the Food and Drug Administration. The study will explore how different nicotine concentrations and forms affect satisfaction, appeal, and switching behavior from cigarettes or ST to ONPs, as well as examine changes in oral microbiome interactions related to switching. The study has two phases. In Phase I, participants are randomly assigned to use one of four ONP products or their usual brand of cigarette or ST, with varying nicotine concentrations and forms. They will insert the ONP or use their usual product during study visits with blood samples taken at multiple time points. Phase II includes a one-week washout period using usual products, a control week with daily diary surveys via text, and then randomization to one of four ONP types for four weeks with additional study visits and oral mucosa sample collection. Participants will attend several study visits over up to three months, using study products and providing blood and oral mucosa samples. They will report tobacco use daily through text surveys during the control week. Researchers will measure nicotine delivery, product liking, craving and withdrawal suppression, and rates of switching to ONPs. The study also includes purchase task assessments and safety monitoring throughout the participation period.
CONDITIONS
Brief Title
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read and speak English
- At least 21 years old
- Willing to provide informed consent
- Willing to abstain from all tobacco, nicotine, and marijuana use for at least 12 hours before Phase 1 visits
- Willing to attend all study visits and use study oral nicotine pouches
- Owns a smartphone and can receive text messages with survey links
- Negative pregnancy test during Phase 1 visits 1-5 and Phase 2 visit 1 if able to become pregnant
- Exhaled carbon monoxide reading less than 10 during Phase 1
- For cigarette smokers: smoked at least 100 cigarettes ever, daily smoking for past 3 months, currently smoking at least 5 cigarettes per day
- For smokeless tobacco users: daily moist snuff use for past 3 months, using at least 1.5 cans per week
You will not qualify if you...
- Unstable or significant psychiatric conditions (stable past conditions allowed)
- History of cardiac event or distress within past 3 months
- Currently pregnant, planning pregnancy, or breastfeeding
- Currently trying or planning to quit all tobacco in next 3 months
- Oral or systemic health issues affecting oral microbiome or epithelium, including fewer than 21 teeth, diabetes mellitus, or autoimmune diseases like rheumatoid arthritis or lupus
- For cigarette smokers: use of non-cigarette tobacco products 10 or more days in past 30 days
- For cigarette smokers: lung diseases such as uncontrolled asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- For cigarette smokers: roll-your-own cigarette smokers
- For smokeless tobacco users: use of non-moist-snuff tobacco products 10 or more days in past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
5 visits over up to 3 months
Duration - 1 week
Participants use their usual brand of smokeless tobacco or cigarettes during a washout period.
No visits during this period
Duration - 1 week
Participants continue regular use of smokeless tobacco or cigarettes and record tobacco use daily via text message surveys.
Daily diary surveys via text message
Duration - 4 weeks
Participants switch to one of four study oral nicotine pouch products and use them for 4 weeks, attending 2 study visits and undergoing oral mucosa sample collection.
2 study visits
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
9
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