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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called High Nicotine Dose and a behavioral approach called Low Nicotine Dose for people with cigarette smoking, nicotine dependence, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 \[70 tins\])