RecruitingNot ApplicableNCT06678789

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

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

Enrollment

50 participants

Start Date

Feb 14, 2025

Study Type

INTERVENTIONAL

Conditions

Smoking Cessation Nicotine Dependence Cigarette Smoking

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

Min Age: 21 Years

Inclusion Criteria5

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 Criteria5

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).

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALHigh Nicotine Dose

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 \[70 tins\])

BEHAVIORALLow Nicotine Dose

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 \[70 tins\])