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RECRUITING
NCT06043362
NA

Use of Nicotine Pouches Among Daily Smokers

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2024-09-17

Completion Date

2028-08

Last Updated

2025-10-01

Healthy Volunteers

Yes

Interventions

OTHER

0 mg nicotine pouch

Oral nicotine pouches that contain 0 mg of nicotine

OTHER

3 mg nicotine pouch

Oral nicotine pouches that contain 3 mg of nicotine

OTHER

6 mg nicotine pouch

Oral nicotine pouches that contain 6 mg of nicotine

OTHER

Smooth nicotine pouch

Non-flavored nicotine pouches that are characterized as smooth.

OTHER

Wintergreen nicotine pouch

Menthol flavored nicotine pouches that are characterized as wintergreen.

Locations (2)

Penn State College of Medicine

Hershey, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States