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Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
Sponsor: Altria Client Services LLC
Summary
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.
Official title: Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial
Key Details
Gender
All
Age Range
22 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-09-11
Completion Date
2025-06
Last Updated
2024-07-11
Healthy Volunteers
Yes
Conditions
Interventions
Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)
Access 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
Access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
Non-Flavored then complete flavor on! nicotine pouches
Access 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
Locations (1)
Rose Research Center
Raleigh, North Carolina, United States