Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial
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.
Description
This open label randomized controlled study (target n=400) among adults who smoke will evaluate the impact of differential availability of research products on cigarette smoking. All products will be on!® 4mg nicotine pouch products. In this design, there are three configurations: 1. Access to complete flavor profile (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) for the entire six-week trial period (Group I); 2. Access to Original only for the entire six-week trial period (Group IIa); and 3. Access to Original only for the first three-week period and then access to compl…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Has signed the Informed Consent Form (ICF) and is able to read and understand the information provided in the ICF. 2. Healthy adults who smoke cigarettes and are 22 to 65 years of age (inclusive) at screening. 3. Smokes an average of at least 5 cigarettes per day for the last 12 months. 4. Does not intend to use an FDA-approved treatment for nicotine dependence within the next 60 days (as assessed at screening). 5. Interested in replacing combustible cigarettes with a smoke-free tobacco product. 6. Willing and able to comply with the requirements of the study. 7. Owns a…
Interventions
- OtherAccess 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.
- OtherAccess to Original on! 4mg nicotine pouches
Access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
- OtherNon-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
Location
- Rose Research CenterRaleigh, North Carolina