Actively Recruiting
Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
Led by Altria Client Services LLC · Updated on 2024-07-11
400
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
A
Altria Client Services LLC
Lead Sponsor
R
Rose Research Center, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has signed the informed consent form and can understand the information provided
- Healthy adults aged 22 to 65 years who smoke cigarettes
- Smokes an average of at least 5 cigarettes per day for the past 12 months
- Does not plan to use FDA-approved nicotine dependence treatment in the next 60 days
- Interested in replacing cigarettes with a smoke-free tobacco product
- Willing and able to comply with study requirements
- Owns a smartphone with text message and data capabilities compatible with study surveys
You will not qualify if you...
- Participant enrollment numbers for the study or subgroup have been met
- Participant or their close relatives or household members are current or former employees of the tobacco or e-vapor industry
- Participant or their close relatives or household members are involved in litigation with tobacco or e-vapor companies
- Participant or their close relatives or household members are current or former employees of marketing, media, regulatory, advocacy, or legal firms related to tobacco
- Participant reports being in poor health
- Participants of childbearing potential with a positive pregnancy test, nursing, or planning pregnancy during the study
- Allergy or sensitivity to menthol, menthol-containing products, or phenylalanine
- Any other self-reported health restrictions
- Self-reported cardiovascular disease, cancer, diabetes, or treatment for high blood pressure
- Self-reported gum or periodontal disease, bleeding, open mouth sores, or ulcers
- Plans to stop using tobacco products within the next 60 days
- Participation in tobacco research studies within the past 30 to 90 days
- Unable to read, speak, or understand English
- Current or past regular use of nicotine pouch products
- Smoking marijuana more than once a week
- Childbearing potential participants not agreeing to medically appropriate birth control or abstinence during and 30 days after the trial
- Taking psychoactive medications such as antipsychotics or mood stabilizers
- Unable to participate due to medical, psychiatric, or social reasons as judged by study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rose Research Center
Raleigh, North Carolina, United States, 27617
Actively Recruiting
Research Team
H
Hui Cheng, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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