NCT06043362 · Milton S. Hershey Medical Center
Use of Nicotine Pouches Among Daily Smokers
What this study is about
The purpose of this clinical trial is to understand the health effects of a new taken by mouth 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Commonly smoke ≥ 5 cigarettes per day (at least 2 days/week) for at least the prior 12 months
- Exhaled CO measurement of ≥ 6 parts per million at baseline
- Must be interested in reducing cigarette consumption by at least 50% and willing to try nicotine pouches
- Able to understand, read and write in English
- Access to e-mail and a smartphone/computer that has reliable internet connection
- Able to understand and give informed consent
Exclusion criteria
- Plans to quit smoking within the next 30 days
- Currently pregnant, breastfeeding, or planning to become pregnant in the next 6 months
- Recent (past 3 months) unstable illness that may increase risks of participation or ability to participate fully (e.g. hospitalization for a mental health condition or substance use disorder in prior 6 months, stroke or myocardial infarction in the past year)
- Serious current respiratory diseases (e.g. exacerbations of asthma or chronic obstructive pulmonary disease \[COPD\], requiring oxygen or oral prednisone), kidney disease (e.g. requiring dialysis), liver disease (e.g cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data
- Use of a nicotine pouch or other non-cigarette nicotine product (e-cigarette, pipe, cigar, chew, snus, hookah, IQOS) for 5 or more days in the past 28 days
- Use of illegal drugs daily or weekly in the past 3 months
- Use of combustible (smoked) recreational or medical marijuana weekly in the past 3 months (less frequent smoked medical marijuana or use of other forms of medical marijuana are ok)
- Other member of the household currently participating in the study
- Any other condition that in the opinion of the investigator would make it unlikely that the participant could comply with the study protocol
Where
- Hershey, Pennsylvania
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations