NCT06315881 · Ohio State University Comprehensive Cancer Center
Informing Oral Nicotine Pouch Regulations to Promote Public Health
What this study is about
This clinical trial evaluates the characteristics of taken by mouth 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).
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
DRUG
Cigarette
Smoke usual brand cigarette
DRUG
Nicotine Oral Pouch
Insert low FBN R/S ONP
DRUG
Nicotine Oral Pouch
Insert low FBN \> 99% S ONP
DRUG
Nicotine Oral Pouch
Insert high R/S ONP
DRUG
Nicotine Oral Pouch
Insert high FBN \> 99% ONP
DRUG
Smokeless Tobacco
Insert ST
OTHER
Survey Administration
Ancillary studies
OTHER
Text Message-Based Navigation Intervention
Receive text with a link to daily diary surveys
Primary outcome measures
Increased nicotine delivery
Time frame: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of oral nicotine pouches (ONPs) relative to cigarettes and smokeless tobacco (ST). Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Liking
Time frame: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Craving/withdrawal suppression
Time frame: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Rate of switching to ONP
Time frame: Up to 3 months
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Rate of switching to ONPs
Time frame: Up to 3 months
Data will be used to evaluate the effects of nicotine concentration, form and isomer on switching from cigarettes or ST to ONPs either partially or completely. Logistic regression models will be used to examine whether differences in form and isomer significantly impact switching.
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
- At least 21 years old
- Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
- Willing to attend all study visits and use study ONPs
- Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)
- Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
- Exhaled carbon monoxide (CO) reading \< 10 (Phase 1)
- CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)
- ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week (as in Pickworth et al., 2014)
Exclusion criteria
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- History of cardiac event or distress within the past 3 months
- Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit \[acute use of usual product and study ONPs\] and Phase 2 study visit 1 \[distribution of study ONPs for outpatient ad libitum use\])
- Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
- Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)
- CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days
- CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
- CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers
- ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days
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 Apr 27, 2026 · Source of record for eligibility and locations