NCT06678789 Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches
| NCT ID | NCT06678789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Cigarette Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-02-14 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Amanda Palmer, PhD.
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06678789 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Cigarette Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678789 currently recruiting?
Yes, NCT06678789 is actively recruiting participants. Contact the research team at ogretmet@musc.edu for enrollment information.
Where is the NCT06678789 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06678789 clinical trial?
NCT06678789 is sponsored by Medical University of South Carolina. The principal investigator is Amanda Palmer, PhD. at Medical University of South Carolina. The trial plans to enroll 50 participants.