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

NCT06072547 | Recruiting DMC

• 1 other identifier: ALCS-REG-23-04-OTDN
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 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

Cigarette Smoking Behavior

Keywords

on! Nicotine Pouches; Reduction in Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Change in cigarette-related toxicant exposure

  50% reduction in carbon monoxide (CO) readings from baseline (yes/no)

  End of Week 3, End of Week 6

• Cigarette-related toxicant exposure

  Reduction in numeric expired air CO readings

  End of Week 3, End of Week 6

Secondary Outcomes (3)

• Change in self-reported cigarette consumption

  End of Week 3, End of Week 6

• CO-verified smoking abstinence

  End of Week 3, End of Week 6

• Number of cigarettes smoked

  End of Week 3, End of Week 6

Study Arms (3)

Complete flavor profile of on! nicotine pouches

EXPERIMENTAL

This study arm will provided with access to all varieties of 4mg on! nicotine pouch products throughout the trial.

Other: Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)

Non-Flavored on! nicotine pouches only

ACTIVE COMPARATOR

This study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.

Other: Access to Original on! 4mg nicotine pouches

Non-Flavored then complete flavor on! nicotine pouches

ACTIVE COMPARATOR

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.

Other: Non-Flavored then complete flavor on! nicotine pouches

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.

Also known as: Flavored on! nicotine pouches

Complete flavor profile of on! nicotine pouches

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 on! nicotine pouches only

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

Non-Flavored then complete flavor on! nicotine pouches

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Altria Client Services LLC: lead
• Rose Research Center, LLC: collaborator

Study Sites (1)

Rose Research Center

Raleigh, North Carolina, 27617, United States

RECRUITING

Related Publications (1)

• Cheng HG, Rose JE, Karelitz JL, Botts DR, Botts TL, Willette PN, Cohen G. Effect of Flavored on! Nicotine Pouch Products on Smoking Behaviors: Protocol for a Sequential, Multiple Assignment, Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 21;13:e56565. doi: 10.2196/56565.

  PMID: 38905632 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Fruit; SPEN protein, human; Coffee

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Beverages

Study Officials

• Hui Cheng, PhD

  ALCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Cheng, PhD

CONTACT

5175998785; hui.cheng@altria.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study involves two randomizations, one at the beginning of the study and another at the end of week 3.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 10, 2023
• Study Start: September 11, 2023
• Primary Completion: November 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)