Trial Summary
What is the purpose of this trial?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
This trial is for individuals who are currently cigarette smokers and want to switch to a less harmful alternative. Participants will be asked to use tobacco-free nicotine pouches with varying nicotine levels over 4 weeks, provide breath and cheek swab samples, and answer questions about their tobacco use.Inclusion Criteria
I am 21 years old or older.
I have been a regular smoker, smoking 5 or more cigarettes daily for over a year.
I have used TNF blockers less than 5 times in my life.
Exclusion Criteria
I do not have any health conditions that prevent me from using nicotine replacement therapy.
Treatment Details
The study is testing the effectiveness of low versus high nicotine dose in tobacco-free oral nicotine pouches at helping cigarette smokers switch away from smoking. It involves an initial visit, a month-long period using the provided pouches, followed by a final visit and additional follow-up.
2Treatment groups
Experimental Treatment
Group I: Low NicotineExperimental Treatment1 Intervention
Low dosage nicotine pouches (3mg)
Group II: High NicotineExperimental Treatment1 Intervention
High dosage nicotine pouches (6mg)
Nicotine Pouches is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Nicotine Pouches for:
- Smoking cessation aid
- Nicotine replacement therapy
🇪🇺 Approved in European Union as Nicotine Pouches for:
- Smoking cessation aid
- Nicotine replacement therapy
Find a clinic near you
Research locations nearbySelect from list below to view details:
Medical University of South CaroloinaCharleston, SC
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator