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Understanding Oral Nicotine Pouch Use in Healthy Volunteers
Sponsor: University of California, San Francisco
Summary
The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are: 1. With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping. 2. With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping. 3. Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape). Participants will: * use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape) * visit the hospital research ward on 4 separate days for 8 hours each day * use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days
Official title: Clinical Pharmacology of Oral Nicotine Pouches
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10
Completion Date
2029-10
Last Updated
2026-09-21
Healthy Volunteers
Yes
Conditions
Interventions
0 mg oral nicotine pouches
placebo
3 mg oral nicotine pouches
low strength oral nicotine pouches
6 mg oral nicotine pouches
high strength oral nicotine pouches
cigarette or e-cigarette
Participants will use their own cigarette or e-cigarette (vape)
Locations (1)
Zuckerberg San Francisco General Hospital
San Francisco, California, United States