Condition: Tobacco Dependence · Sponsor: Milton S. Hershey Medical Center
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.
This description comes directly from the study's public registry record.
Nicolle M Krebs, MS · 717-531-5673 · nkrebs@pennstatehealth.psu.edu
Jonathan Foulds, PhD · 717-531-3504 · jfoulds@pennstatehealth.psu.edu
Always discuss trial participation with your own doctor first.
| Penn State College of Medicine | Hershey, Pennsylvania, United States | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06043362