Exploring the effects of nicotine pouches on daily smokers
Randomized Placebo-controlled Trial of Nicotine Pouches in Smokers
This study is testing whether using a new nicotine pouch can help daily smokers cut down on their cigarette use and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Hershey, Pennsylvania and 1 other locations) |
| Trial ID | NCT06043362 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the health effects of a new oral nicotine pouch and its potential to reduce traditional cigarette smoking among daily smokers. Participants will be randomly assigned to one of six groups based on nicotine strength and flavor, using the pouches over a 16-week period while attempting to reduce their cigarette consumption by at least 75%. The study will measure various health indicators, including biomarkers of toxicant exposure and addiction levels, to assess the impact of nicotine pouch use. The trial will be conducted at two sites to ensure a diverse sample of participants.
Who should consider this trial
Good fit: Ideal candidates are daily smokers who consume at least 5 cigarettes per day and are interested in reducing their smoking.
Not a fit: Patients who plan to quit smoking within the next 30 days or have serious respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative for smokers looking to reduce their cigarette consumption and improve their health.
How similar studies have performed: Other studies have shown promise in using nicotine replacement therapies, but the specific use of nicotine pouches is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hershey, Pennsylvania and 1 other locations
- Penn State College of Medicine — Hershey, Pennsylvania, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Foulds, PhD — Penn State College of Medicine
- Study coordinator: Nicolle M Krebs, MS
- Email: nkrebs@pennstatehealth.psu.edu
- Phone: 717-531-5673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.