NCT06043362 Use of Nicotine Pouches Among Daily Smokers
| NCT ID | NCT06043362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Tobacco Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 375 participants in total. It began in 2024-09-17 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Jonathan Foulds, PhD
PRINCIPAL INVESTIGATOR
Penn State College of Medicine
Frequently Asked Questions
Who can join the NCT06043362 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 70 Years, studying Tobacco Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06043362 currently recruiting?
Yes, NCT06043362 is actively recruiting participants. Contact the research team at nkrebs@pennstatehealth.psu.edu for enrollment information.
Where is the NCT06043362 trial being conducted?
This trial is being conducted at Hershey, United States, Houston, United States.
Who is sponsoring the NCT06043362 clinical trial?
NCT06043362 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Jonathan Foulds, PhD at Penn State College of Medicine. The trial plans to enroll 375 participants.