Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of tobacco-free nicotine pouches, which are a less harmful option compared to traditional cigarettes, in helping smokers quit. The researchers want to find out if using these pouches with different levels of nicotine can support people in switching away from smoking. If you're a current smoker, over the age of 21, and have been smoking regularly for at least a year, you might be eligible to participate. You should not have used nicotine pouches more than five times in your life and must be willing to attend two visits in Charleston for testing.

If you join the study, you'll answer questions about your smoking habits and provide some samples at the first visit. Then, you'll receive a 28-day supply of nicotine pouches to use as you try to stop smoking. After four weeks, you'll return for a final visit and answer more questions about your experience. It's important to note that you should not be using other tobacco products or smoking cessation medications during the trial. This study is an opportunity to explore a new way to quit smoking while contributing to important research.

Gender

ALL

Eligibility criteria

• 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).