Use of Nicotine Pouches Among Daily Smokers

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06043362
Status
Recruiting
Apply to this trial

Conditions

  • Tobacco Dependence

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • 0 mg nicotine pouch — OTHER
    Oral nicotine pouches that contain 0 mg of nicotine
  • 3 mg nicotine pouch — OTHER
    Oral nicotine pouches that contain 3 mg of nicotine
  • 6 mg nicotine pouch — OTHER
    Oral nicotine pouches that contain 6 mg of nicotine
  • Smooth nicotine pouch — OTHER
    Non-flavored nicotine pouches that are characterized as smooth.
  • Wintergreen nicotine pouch — OTHER
    Menthol flavored nicotine pouches that are characterized as wintergreen.

Study Details

The purpose of this clinical trial is to understand the health effects of a new oral nicotine pouch, and also to understand if this product can help reduce traditional cigarette smoking. The main aims are: 1. Understand the impact of nicotine pouch use on toxicant exposure biomarkers, and indicators of potential harms to health. 2. Examine the influence of nicotine pouch use on conventional tobacco product use (cigarettes). Participants will be randomized to one of six nicotine pouch groups (3 nicotine strengths, each with 2 potential flavors) to use over 16 weeks and asked to reduce their cigarette smoking over that time by at least 75% by substituting with the use of the nicotine pouches. Researchers will compare the outcomes of the different nicotine pouch strengths and flavors to each other. Participants will be asked to complete study questionnaires and provide urine, exhaled carbon monoxide, and mouth cell samples, and other health measurements.

Key Dates

Start date
Sep 17, 2024
Status verified
Sep 2025
Primary completion
Jan 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 0 mg + Smooth flavor
    Participants are provided with zero strength (0 mg) nicotine pouches with smooth flavor.
  • Experimental: 3 mg + Smooth flavor
    Participants are provided with medium strength (3 mg) nicotine pouches with smooth flavor.
  • Experimental: 6 mg + Smooth flavor
    Participants are provided with high strength (6 mg) nicotine pouches with smooth flavor.
  • Experimental: 0 mg + Wintergreen flavor
    Participants are provided with zero strength (0 mg) nicotine pouches with wintergreen flavor.
  • Experimental: 3 mg + Wintergreen flavor
    Participants are provided with medium strength (3 mg) nicotine pouches with wintergreen flavor.
  • Experimental: 6 mg + Wintergreen flavor
    Participants are provided with high strength (6 mg) nicotine pouches with wintergreen flavor.

Primary Outcome Measure

Concentration of urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) [ Time Frame: Week 16 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Penn State College of MedicineHersheyPennsylvania17033
Nicolle M Krebs, MS
[email protected]
717-531-5673
Jonathan Foulds, PhD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jason Robinson, PhD
[email protected]
713-745-3581

Find similar trials in Hershey, PA

By research site
Penn State College of Medicine· Hershey, PAUniversity of Texas MD Anderson Cancer Center· Houston, TX

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