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Use of Nicotine Pouches Among Daily Smokers

NCT06043362 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Tobacco Dependence

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Jonathan Foulds, PhD · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2028-01-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043362 on ClinicalTrials.gov