Understanding Oral Nicotine Pouch Use in Healthy Volunteers

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07829939
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 0 mg oral nicotine pouches — DRUG
    placebo
  • 3 mg oral nicotine pouches — DRUG
    low strength oral nicotine pouches
  • 6 mg oral nicotine pouches — DRUG
    high strength oral nicotine pouches
  • cigarette or e-cigarette — DRUG
    Participants will use their own cigarette or e-cigarette (vape)

Study Details

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

Key Dates

First listed
Sep 21, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    placebo (0 mg nicotine pouches) used on one study day (8 hours)
  • Experimental: 3 mg ONP
    3 mg oral nicotine pouches used on one study day (8 hours)
  • Experimental: 6 mg ONP
    6 mg oral nicotine pouches used on one study day (8 hours)
  • Experimental: Inhaled nicotine
    Participants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours)

Primary Outcome Measure

With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping. [ Time Frame: 7 hours post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94143
Lisa Lawrence, BA
[email protected]
415-502-2465
Armando Barraza, BA
[email protected]
4155022465
Neal Benowitz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Zuckerberg San Francisco General Hospital· San Francisco, CA

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