Exploring the effects of nicotine pouches on daily smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.