Status:
RECRUITING
Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
Lead Sponsor:
Altria Client Services LLC
Collaborating Sponsors:
Rose Research Center, LLC
Conditions:
Cigarette Smoking Behavior
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief 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 th...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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).
- Interested in replacing combustible cigarettes with a smoke-free tobacco product.
- Willing and able to comply with the requirements of the study.
- Owns a smart phone with text message and data capabilities compatible with necessary surveys.
Exclusion
- 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.
- Participant self-reports being "in poor health."
- Participants of childbearing potential (CBP) who have a positive pregnancy test (as assessed at screening) or are nursing or planning to become pregnant during their participation.
- Participant has an allergy/sensitivity to menthol or menthol-containing products or phenylalanine.
- Participant has any other self-reported health restrictions.
- Participant self-reports cardiovascular disease, cancer, diabetes, or is being treated for high blood pressure.
- Participant self-reports periodontal disease, gum disease or bleeding, open mouth sores or ulcers.
- Participant self-reports as wanting to stop using tobacco products in the next 60 days.
- Participant has participated in one tobacco research study in the past 30 days OR a tobacco research study lasting two weeks or longer in the past 90 days.
- Participant is unable to read, speak or understand English.
- Participants who ever used at least a pack of nicotine pouch products or currently uses nicotine pouch products.
- Participant who smokes marijuana more than once a week.
- Heterosexually active participants of CBP (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of birth control (or remain abstinent) during the course of the trial and for 30 days after the last use of the research product. Medically acceptable methods of birth control include: vasectomy, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, patch, or implanted), condom with spermicide, or sponge with spermicide.
- Taking psychoactive medications (e.g., antipsychotics or mood stabilizers).
- Cannot participate in the study for any reason (e.g., medical, psychiatric, and or social reason) as judged by the Investigator or designated medical staff based on all available information from the screening period.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06072547
Start Date
September 11 2023
End Date
June 1 2025
Last Update
July 11 2024
Active Locations (1)
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1
Rose Research Center
Raleigh, North Carolina, United States, 27617