Evaluating oral nicotine pouches as a safer alternative to tobacco products
Informing Oral Nicotine Pouch Regulations to Promote Public Health
This study tests if using oral nicotine pouches can be a safer alternative for people trying to quit cigarettes and smokeless tobacco.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06315881 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the characteristics of oral nicotine pouches (ONPs) to determine their effectiveness as a substitute for cigarettes and smokeless tobacco products. Participants will be randomized to use different ONP products with varying nicotine concentrations and forms, while also providing blood samples to evaluate their satisfaction and appeal compared to traditional tobacco products. The study aims to gather data on the potential for ONPs to facilitate switching from high-risk tobacco products to lower-risk alternatives, as well as to explore changes in oral microbiome interactions related to this switch.
Who should consider this trial
Good fit: Ideal candidates for this study are adult smokers or smokeless tobacco users aged 21 and older who are willing to switch to oral nicotine pouches.
Not a fit: Patients who do not currently use tobacco products or those who are not willing to abstain from tobacco use prior to the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative for tobacco users, potentially reducing the health risks associated with traditional tobacco products.
How similar studies have performed: Other studies have shown promise in evaluating alternative nicotine delivery systems, but this specific approach to ONPs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brittney L Keller-Hamilton, PhD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.