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Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

RecruitingNAAges 21 Years - anyAllMedical University of South Carolina
NCT06678789 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

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📋 Eligibility rules (as published)
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).
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What it tests

  • High Nicotine Dose
  • Low Nicotine Dose
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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