Impact of flavored nicotine pouches on cigarette smoking behavior

Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial

This study tests if flavored nicotine pouches can help adults reduce their cigarette smoking compared to using non-flavored pouches.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Altria Client Services LLC (Industry-sponsored)
• Locations: 1 site (Raleigh, North Carolina)
• Trial ID: NCT06072547 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate how flavored on!® nicotine pouch products influence cigarette smoking behaviors among adults. Participants will be randomly assigned to different groups, with some having access to a complete flavor profile of nicotine pouches while others will only have access to a non-flavored option. Over a six-week period, researchers will monitor the reduction in cigarette consumption through daily and weekly surveys, as well as follow-up assessments. The study will involve approximately 400 participants and will assess the effectiveness of flavored products in aiding smoking cessation.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 22 to 65 who smoke at least 5 cigarettes per day and are interested in switching to a smoke-free product.

Not a fit: Patients who are not regular cigarette smokers or those planning to use FDA-approved nicotine dependence treatments within the next 60 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach to help smokers reduce or quit cigarette use through flavored nicotine alternatives.

How similar studies have performed: While the specific approach of using flavored nicotine pouches is relatively novel, previous studies have shown that flavoring can enhance the appeal of nicotine products and may aid in smoking cessation efforts.

Eligibility criteria

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 smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. Participant enrollment numbers met (in sub-group or entire study).
2. 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.
3. 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.
4. 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.
5. Participant self-reports being "in poor health."
6. 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.
7. Participant has an allergy/sensitivity to menthol or menthol-containing products or phenylalanine.
8. Participant has any other self-reported health restrictions.
9. Participant self-reports cardiovascular disease, cancer, diabetes, or is being treated for high blood pressure.
10. Participant self-reports periodontal disease, gum disease or bleeding, open mouth sores or ulcers.
11. Participant self-reports as wanting to stop using tobacco products in the next 60 days.
12. 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.
13. Participant is unable to read, speak or understand English.
14. Participants who ever used at least a pack of nicotine pouch products or currently uses nicotine pouch products.
15. Participant who smokes marijuana more than once a week.
16. 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.
17. Taking psychoactive medications (e.g., antipsychotics or mood stabilizers).
18. 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.

Where this trial is running

Raleigh, North Carolina

• Rose Research Center — Raleigh, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Hui Cheng, PhD — Alcs
• Study coordinator: Hui Cheng, PhD

Conditions Cigarette Smoking Behavior; on! Nicotine Pouches; Reduction in Cigarette Smoking