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NOT YET RECRUITING
NCT07829939
PHASE1

Understanding Oral Nicotine Pouch Use in Healthy Volunteers

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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

Interventions

DRUG

0 mg oral nicotine pouches

placebo

DRUG

3 mg oral nicotine pouches

low strength oral nicotine pouches

DRUG

6 mg oral nicotine pouches

high strength oral nicotine pouches

DRUG

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