Evaluating nicotine pouches for quitting smoking

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 study assesses the effectiveness of tobacco-free oral nicotine pouches at different nicotine levels in helping smokers switch from cigarettes. Participants will be recruited to use either high (6 mg) or low (3 mg) nicotine pouches over a 28-day period, during which they will provide feedback on their tobacco use and submit biological samples. The study aims to measure outcomes such as complete switching from cigarettes, reduction in smoking, changes in biomarkers of harm, and levels of nicotine dependence. Participants will attend two in-person visits at the Medical University of South Carolina for assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 21+
* current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
* have not used TNFPs more than 5 times during their lifetime
* willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
* have internet access

Exclusion Criteria:

* Lack of proficiency in English.
* Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
* Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
* Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
* Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Amanda Palmer, PhD. — Medical University of South Carolina
• Study coordinator: Talia Ogretman
• Email: ogretmet@musc.edu
• Phone: 843-259-8111

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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.