Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers
Milton S. Hershey Medical Center
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.
Description
Nicotine Pouches represent a rapidly growing category in the U.S. tobacco market, but little is known about their health effects (including addiction) or effects on cigarette smoking. The investigators propose to use a randomized controlled trial methodology to inform FDA on the effects of nicotine pouch use in smokers interested in reducing their smoking but not quitting smoking. The specific aim of this proposal is to recruit a cohort of 330 current daily smokers with an interest in reducing smoking, and to measure a comprehensive battery of behavioral and health indicators at baseline, and…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- Yes
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 pregnan…
Interventions
- Other0 mg nicotine pouch
Oral nicotine pouches that contain 0 mg of nicotine
- Other3 mg nicotine pouch
Oral nicotine pouches that contain 3 mg of nicotine
- Other6 mg nicotine pouch
Oral nicotine pouches that contain 6 mg of nicotine
- OtherSmooth nicotine pouch
Non-flavored nicotine pouches that are characterized as smooth.
- OtherWintergreen nicotine pouch
Menthol flavored nicotine pouches that are characterized as wintergreen.
Locations (2)
- Penn State College of MedicineHershey, Pennsylvania
- University of Texas MD Anderson Cancer CenterHouston, Texas