The goal of this clinical trial is to learn about the role of flavored on!® nicotine pouch products (the research products), an oral tobacco-leaf-free product, in the replacement of cigarettes with the use of the research products among adults who smoke cigarettes. The main question it aims to answer is whether flavored (vs. non-flavored) research products generate greater reduction of cigarette smoking among adults who smoke cigarettes.
Participants will be provided with research products to use for 6 weeks. Researchers will compare the reduction in cigarette smoking between participants with access to a complete flavor profile of research products and participants with access to only the Original (non-flavored) variety of research product to see if reduction in cigarette smoking is greater among those with access to flavored research products.
Has signed the Informed Consent Form (ICF) and is able to read and understand the information provided in the ICF.
Healthy adults who smoke cigarettes and are 22 to 65 years of age (inclusive) at screening.
Smokes an average of at least 5 cigarettes per day for the last 12 months.
Does not intend to use an FDA-approved treatment for nicotine dependence within the next 60 days (as assessed at screening).
Participant enrollment numbers met (in sub-group or entire study).
Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member, is a current or former employee of the tobacco or e-vapor industry.
Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member is a named party or class representative in litigation involving a tobacco or e-vapor company.
Participant, or their first-degree relative (e.g., parent, sibling, child, spouse), or household member, is a current or former employee of a marketing consultant, market research firm, advertising or promotions agency, television or radio station, magazine or newspaper, government regulatory agency or public policy advocacy group, or law firm or legal department of a company.
Parallel
Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)
Other interventionAccess to all varieties of on! 4mg nicotine pouch products (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), throughout the trial.
Access to Original on! 4mg nicotine pouches
Other interventionAccess to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
Non-Flavored then complete flavor on! nicotine pouches
Other interventionAccess to non-flavored (i.e., Original) on! 4mg nicotine pouch products during the first 3 weeks and then access to all varieties (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) of on! 4mg nicotine pouch products during the rest of the trial
Change in cigarette-related toxicant exposure
50% reduction in carbon monoxide (CO) readings from baseline (yes/no)
Cigarette-related toxicant exposure
Reduction in numeric expired air CO readings
Change in self-reported cigarette consumption
50% reduction in self-reported cigarette consumption from baseline (Yes/No)
CO-verified smoking abstinence
Cigarette smoking abstinence in the past 7 days based on self-report and CO\<6ppm
Number of cigarettes smoked
Numeric number of cigarettes smoked (based on self-report)
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Altria Client Services LLC
Lead sponsor
Rose Research Center, LLC
Collaborator
