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.
The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
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 \[70 tins\])
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 \[70 tins\])
Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGSwitching
Switching will be defined at 7-day point-prevalence biochemically-confirmed abstinence from cigarettes alongside self-reported use of nicotine pouches. Non-responders and missing data will be coded as smoking.
Time frame: Day 28 and Day 56
Smoking Reduction
Baseline and daily survey data will be used to calculate the change of smoking (average cigarettes per day) between groups from baseline to end of sampling.
Time frame: Day 28 and Day 56
Tobacco-Free Oral Nicotine Pouches (TFNP) Use
Daily surveys will capture number of days of TFNP use, regardless of smoking.
Time frame: Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.