Actively Recruiting
Use of Nicotine Pouches Among Daily Smokers
Led by Milton S. Hershey Medical Center · Updated on 2025-10-01
375
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Use of Nicotine Pouches Among Daily Smokers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Smoke at least 5 cigarettes per day on at least 2 days per week for at least 12 months
- Exhaled carbon monoxide level of 6 parts per million or higher at baseline
- Interested in reducing cigarette smoking by at least 50% and willing to try nicotine pouches
- Able to read, write, and understand English
- Have access to email and a smartphone or computer with reliable internet
- Able to understand and provide informed consent
You will not qualify if you...
- Planning to quit smoking within the next 30 days
- Currently pregnant, breastfeeding, or planning to become pregnant within 6 months
- Recent unstable illness in past 3 months that increases participation risk or limits ability (e.g., recent hospitalization for mental health or substance use disorder, stroke, or heart attack within past year)
- Serious respiratory diseases requiring oxygen or prednisone, kidney disease requiring dialysis, liver disease such as cirrhosis, or other medical problems/medications that affect safety or biomarker data
- Use of nicotine pouches or other non-cigarette nicotine products for 5 or more days in past 28 days
- Use of illegal drugs daily or weekly in past 3 months
- Use of smoked recreational or medical marijuana weekly in past 3 months (less frequent or other forms allowed)
- Another household member currently in this study
- Any other condition that may prevent compliance with the study protocol as judged by the investigator
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Trial Site Locations
Total: 2 locations
1
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicolle M Krebs, MS
CONTACT
J
Jonathan Foulds, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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