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
189 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 clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.
CONDITIONS
Official Title
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Read and speak English
- At least 21 years old
- Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours before Phase 1 study visits
- Willing to attend all study visits and use study ONPs
- Owns a smartphone and able to receive text messages with survey links
- Negative pregnancy test during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
- Exhaled carbon monoxide reading less than 10 during Phase 1
- For cigarette smokers only: Smoked at least 100 cigarettes, daily smoker for at least the past 3 months, currently smokes at least 5 cigarettes per day
- For smokeless tobacco users only: Moist snuff user daily for at least the past 3 months, uses at least 1.5 cans per week
You will not qualify if you...
- Unstable or significant psychiatric conditions (past stable conditions allowed)
- History of cardiac event or distress within the past 3 months
- Currently pregnant, planning pregnancy, or breastfeeding (verified by urine pregnancy test before Phase 1 and Phase 2 visits)
- Currently trying to quit tobacco, interested in quitting, or planning to quit all tobacco within the next 3 months
- Oral or systemic health issues affecting oral microbiome or epithelium, including fewer than 21 teeth, diabetes, or autoimmune diseases such as rheumatoid arthritis or lupus
- For cigarette smokers only: Use of non-cigarette tobacco products 10 or more times in past 30 days
- For cigarette smokers only: Diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
- For cigarette smokers only: Roll-your-own cigarette smokers
- For smokeless tobacco users only: Use of non-moist snuff tobacco products 10 or more times in past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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