What this study is
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.
What's being tested
- High Nicotine Dose
Intervention · BEHAVIORAL
Will receive a 5-week supply of 6 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins])
- Low Nicotine Dose
Intervention · BEHAVIORAL
Will receive a 5-week supply of 3 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins])
Study details
- Official title
- Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)
- Sponsor
- Medical University of South Carolina
- Conditions
- Cigarette Smoking · Nicotine Dependence · Smoking Cessation
- Enrolling
- 50 people
- Starts
- 2025-02-14
- Est. completion
- 2027-05-28
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMedical University of South Carolina
Charleston, South Carolina, United States
Recruiting
Study team
Sponsor
Medical University of South Carolina
Study ID Pro00139710
Principal investigator
Amanda Palmer, PhD.
Medical University of South Carolina
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.