This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
Yale University
New Haven, Connecticut, United States
Number of Cigarettes Smoked Per Day (Log-transformed)
The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.
Time frame: up to week 4
Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations
Time frame: This will be evaluated at week 4.
Percentage of Smoke Free Days.
The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations
Time frame: up to week 4
Level of Biomarker (NNAL) Among Smokers
Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.
Time frame: baseline and week 4
Subjective Effects of Oral Nicotine Pouches
To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.
Time frame: week 4
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