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

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
Altria Client Services LLC
Study ID
NCT06072547
Status
Recruiting
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Conditions

  • Cigarette Smoking Behavior

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) — OTHER
    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 — OTHER
    Access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
  • Non-Flavored then complete flavor on! nicotine pouches — OTHER
    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

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Jul 2024
Primary completion
Nov 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Complete flavor profile of on! nicotine pouches
    This study arm will provided with access to all varieties of 4mg on! nicotine pouch products throughout the trial.
  • Active Comparator: Non-Flavored on! nicotine pouches only
    This study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
  • Active Comparator: Non-Flavored then complete flavor on! nicotine pouches
    This study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products during the first 3 weeks of the trial and then access to all varieties of 4mg on! nicotine pouch products during the last 3 weeks of the trial.

Primary Outcome Measure

Change in cigarette-related toxicant exposure [ Time Frame: End of Week 3, End of Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rose Research CenterRaleighNorth Carolina27617
Courtney Capps
[email protected]
704-350-2999
Jed E Rose, PhD (PRINCIPAL_INVESTIGATOR)
Perry Willette, MD (SUB_INVESTIGATOR)

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By research site
Rose Research Center· Raleigh, NC

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