RECRUITING

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

Conditions

Cigarette Smoking Behavior on! Nicotine Pouches Reduction in Cigarette Smoking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-11

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06072547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Hui Cheng, PhD

CONTACT

5175998785

hui.cheng@altria.com

Principal Investigator

Hui Cheng, PhD

PRINCIPAL_INVESTIGATOR

ALCS

Study Locations (Sites)

Rose Research Center

Raleigh, North Carolina, 27617

United States

Collaborators and Investigators

Sponsor: Altria Client Services LLC

Hui Cheng, PhD, PRINCIPAL_INVESTIGATOR, ALCS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

on! Nicotine Pouches
Reduction in Cigarette Smoking

Additional Relevant MeSH Terms

Cigarette Smoking Behavior