How nicotine strength and pH affect the feel and appeal of oral nicotine pouches
Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
This trial will test whether different nicotine strengths and pH levels in oral nicotine pouches change how they feel, how appealing they are, and how likely young adult pouch users are to misuse them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 21 Years to 35 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07165808 on ClinicalTrials.gov |
What this trial studies
The study exposes current young adult nicotine pouch users to pouches that vary by nicotine concentration (low vs high) and pH (low vs high) to see how those product features change sensory experience, product appeal, and measures of abuse liability. Participants are confirmed users (positive cotinine) who are not trying to quit and will complete controlled product administration sessions with subjective ratings and behavioral measures. The design permits analysis of both main effects and the interaction between nicotine dose and pH on outcomes that inform regulation. The study is conducted at Emory University's Rollins School of Public Health and excludes participants with pregnancy or cardiovascular/seizure contraindications.
Who should consider this trial
Good fit: Ideal candidates are young adult established nicotine pouch users who currently use pouches (every day or some days), test positive for cotinine, are not planning to quit, and can attend visits at the Emory site.
Not a fit: People planning to stop nicotine, those who are pregnant or breastfeeding, and individuals with a history of stroke, seizures, high blood pressure, or other cardiovascular conditions are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help regulators limit nicotine and pH features in oral pouches to reduce their appeal and misuse among young people.
How similar studies have performed: Prior research on e-cigarette nicotine formulations shows that free-base nicotine can increase appeal and abuse potential, but experimental evidence specific to oral nicotine pouches is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Current established users of nicotine pouches (have used nicotine pouches in the past 30 days \& currently use nicotine pouches every day or someday) * Positive cotinine test via saliva test strip * Those who are unmotivated to quit nicotine use * Read and speak English. * Poly-users of nicotine pouches, e-cigarettes (e.g., vape ≥20 days/month), and tobacco (e.g., ≥4 cigarettes/day for ≥2 years) will be eligible for participation Exclusion Criteria * Planning to cut down or quit using nicotine in the next 30 days * Currently pregnant or breastfeeding * History of stroke, seizures, high blood pressure, heart disease/problems, or cardiovascular disease contraindications for nicotine.
Where this trial is running
Atlanta, Georgia
- Rollins School of Public Health — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Dae Han, PhD — Rollins School of Public Health
- Study coordinator: Dae Hee Han, PhD
- Email: dae.hee.han@emory.edu
- Phone: 404-727-8742
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.