Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorAltria Client Services LLC

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)
  • Access to Original on! 4mg nicotine pouches
  • Non-Flavored then complete flavor on! nicotine pouches

Treatment groups

400 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Altria Client Services LLC

Lead sponsor

Rose Research Center, LLC

Collaborator