Nicotine Pouches for Smokers: A Randomized Trial
Official title: Project 3: Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers
Funded at Pennsylvania State Univ Hershey Med Ctr · NIH-11394451 · Data updated 2026-11-12
A invited group of current smokers will try nicotine pouches with different nicotine levels to see how these products affect smoking behavior and health over about four months.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Pennsylvania State Univ Hershey Med Ctr NIH-funded |
| Lab location | 1 site (Hershey, United States) |
| Project start | September 30, 2023 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $1,020,420 |
| NIH project number | 5U54DA058271-04 |
| Project ID | NIH-11394451 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adult daily smokers interested in reducing their smoking but not quitting, who are willing to use nicotine pouch products as part of the study.
✕Less likely to help
Non-smokers, former smokers, or individuals unwilling to use nicotine pouches or participate in follow-up visits are unlikely to benefit.
What this research studies
This trial tests whether using nicotine pouches at 0 mg, 3 mg, or 6 mg nicotine influences smoking reduction, addiction, and health markers in daily smokers who want to cut back but not quit. Participants are randomly assigned to one of the pouch types (0, 3, or 6 mg) and to flavor options (Smooth or Wintergreen) in a double-blind setup across two sites. Researchers will monitor smoking status, toxic exposure, and oral and systemic health indicators at baseline and over 16 weeks. The study focuses on how nicotine pouch content and flavors affect biomarkers like NNAL, carbon monoxide, and DNA adducts, as well as addiction scores and oxidative stress. Results could inform FDA decisions about the health impact and design of nicotine pouches for smokers who are not planning to quit.
Why it matters
Potential benefit: If successful, the study could clarify whether nicotine pouches help reduce smoking and exposure to harmful substances.
How similar studies have gone: Previous studies in nicotine-containing products have shown mixed results; this trial adds rigorous, blinded, dose-ranging data.
Where this research is happening
-
Pennsylvania State Univ Hershey Med Ctr
Hershey, United States Active
Researchers
- Principal investigator: Foulds, Jonathan — Pennsylvania State Univ Hershey Med Ctr
- Study coordinator: Foulds, Jonathan
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.