Cigarette Smoking BehaviorNCT06072547
Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
A study testing Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), Access to Original on! 4mg nicotine pouches and Non-Flavored then complete flavor on! nicotine pouches in people with Cigarette Smoking Behavior, run by Altria Client Services LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), Access to Original on! 4mg nicotine pouches and Non-Flavored then complete flavor on! nicotine pouches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rose Research Center
Raleigh, North Carolina, 27617
Courtney Capps, 704-350-2999, courtney.capps@roseresearchcenter.com
Jed E Rose, PhD
About this study
Official title: Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial
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.
Read the 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 on!® 4mg nicotine pouch products.
In this design, there are three configurations:
- Access to complete flavor profile (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) for the entire six-week trial period (Group I);
- Access to Original only for the entire six-week trial period (Group IIa); and
- Access to Original only for the first three-week period and then access to complete flavor profile for the second three-week period (Group IIb).
This study will involve approximately 7 weeks (including the baseline period) of study participation in a home use test with daily surveys, weekly surveys, and a 6-month follow-up survey after the trial period. Approximately 400 participants will be recruited. A total of 150 participants will be randomized to Group I, 125 to Group IIa, and 125 to Group IIb.
After consenting and screening procedures, participants will be followed for 3-7 days to establish baseline measures of cigarettes smoked per day. During this baseline period at least two CO readings will be collected. Participants randomized into Group I will enter a seven-day trial period to try all flavors of research products. This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete five additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.
Likewise, following the baseline period, participants randomized into Group II will be provided with the Original variety of research products to use for the next three weeks. At the three-week point, participants in Group IIa will continue with the Original variety of research product for the remaining three weeks and Group IIb will switch to having access to all flavors of research products for the remaining three weeks. Group IIb will enter a seven-day trial period to try all flavors of research products (a total of seven packs - one of each flavor will be provided). This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete two additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.
Participants will be invited to complete a six-month follow-up survey to gain insights about their tobacco use and related factors after the end of the product trial.
Analysis will be conducted to compare outcomes between:
- Group I vs. Group II at week 3
- Group I vs. Group IIa at week 6
- Group IIa vs. Group IIb at week 6 among non-responders at week3
- Group IIa and Group IIb at week 6 among responders at week 3
- Group I and Groups IIb at week 6
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), Access to Original on! 4mg nicotine pouches, Non-Flavored then complete flavor on! nicotine pouches
- Keywords
- on! Nicotine Pouches, Reduction in Cigarette Smoking
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)Other
Also called Flavored on! nicotine pouches
Access to all varieties of on! 4mg nicotine pouch products (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), throughout the trial.
Access to Original on! 4mg nicotine pouchesOther
Access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial.
Non-Flavored then complete flavor on! nicotine pouchesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Non-Flavored then complete flavor on! nicotine pouches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarette-related toxicant exposure
50% reduction in carbon monoxide (CO) readings from baseline (yes/no)
Measured: End of Week 3, End of Week 6
Cigarette-related toxicant exposure
Reduction in numeric expired air CO readings
Measured: End of Week 3, End of Week 6
Secondary outcomes (3)
Change in self-reported cigarette consumption
50% reduction in self-reported cigarette consumption from baseline (Yes/No)
Measured: End of Week 3, End of Week 6
CO-verified smoking abstinence
Cigarette smoking abstinence in the past 7 days based on self-report and CO<6ppm
Measured: End of Week 3, End of Week 6
Number of cigarettes smoked
Numeric number of cigarettes smoked (based on self-report)
Measured: End of Week 3, End of Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Sep 2023
- Primary completionNov 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves two randomizations, one at the beginning of the study and another at the end of week 3.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altria Client Services LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rose Research Center, LLC
- Responsible party
- Sponsor
- Investigators
- Hui Cheng, PhD, Principal investigator, ALCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072547
- Sponsor's protocol ID
- ALCS-REG-23-04-OTDN
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38905632
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a Sequential Multiple Assignment Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06072547
- Acronym / sponsor ID
- ALCS-REG-23-04-OTDN
- Conditions
- Cigarette Smoking Behavior
- Keywords
- on! Nicotine Pouches, Reduction in Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Altria Client Services LLCIndustry (pharma, biotech, devices)
- Collaborators
- Rose Research Center, LLC
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 on!® 4mg nicotine pouch products.
In this design, there are three configurations:
- Access to complete flavor profile (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original) for the entire six-week trial period (Group I);
- Access to Original only for the entire six-week trial period (Group IIa); and
- Access to Original only for the first three-week period and then access to complete flavor profile for the second three-week period (Group IIb).
This study will involve approximately 7 weeks (including the baseline period) of study participation in a home use test with daily surveys, weekly surveys, and a 6-month follow-up survey after the trial period. Approximately 400 participants will be recruited. A total of 150 participants will be randomized to Group I, 125 to Group IIa, and 125 to Group IIb.
After consenting and screening procedures, participants will be followed for 3-7 days to establish baseline measures of cigarettes smoked per day. During this baseline period at least two CO readings will be collected. Participants randomized into Group I will enter a seven-day trial period to try all flavors of research products. This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete five additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.
Likewise, following the baseline period, participants randomized into Group II will be provided with the Original variety of research products to use for the next three weeks. At the three-week point, participants in Group IIa will continue with the Original variety of research product for the remaining three weeks and Group IIb will switch to having access to all flavors of research products for the remaining three weeks. Group IIb will enter a seven-day trial period to try all flavors of research products (a total of seven packs - one of each flavor will be provided). This trial period is intended to allow participants to identify their preferred flavor(s). After the trial period, they will then complete two additional weeks of home use testing with ad libitum product trial of research products with free choice of the flavors available in this study.
Participants will be invited to complete a six-month follow-up survey to gain insights about their tobacco use and related factors after the end of the product trial.
Analysis will be conducted to compare outcomes between:
- Group I vs. Group II at week 3
- Group I vs. Group IIa at week 6
- Group IIa vs. Group IIb at week 6 among non-responders at week3
- Group IIa and Group IIb at week 6 among responders at week 3
- Group I and Groups IIb at week 6
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study involves two randomizations, one at the beginning of the study and another at the end of week 3.
| Arm | Type | Receives |
|---|---|---|
| Complete flavor profile of on! nicotine pouches | Experimental | Other: Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)This study arm will provided with access to all varieties of 4mg on! nicotine pouch products throughout the trial. |
| Non-Flavored on! nicotine pouches only | Active comparator | Other: Access to Original on! 4mg nicotine pouchesThis study arm will provided with access to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial. |
| Non-Flavored then complete flavor on! nicotine pouches | Active comparator | Other: Non-Flavored then complete flavor on! nicotine pouchesThis 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original)Also: Flavored on! nicotine pouchesAccess to all varieties of on! 4mg nicotine pouch products (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), throughout the trial. | Other | Complete flavor profile of on! nicotine pouches |
| Access to Original on! 4mg nicotine pouchesAccess to non-flavored (i.e., Original) 4mg on! nicotine pouch products throughout the trial. | Other | Non-Flavored on! nicotine pouches only |
| Non-Flavored then complete flavor on! nicotine pouchesAccess 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 | Other | Non-Flavored then complete flavor on! nicotine pouches |
Primary outcome
Change in cigarette-related toxicant exposure
Time frame: End of Week 3, End of Week 6
50% reduction in carbon monoxide (CO) readings from baseline (yes/no)
Cigarette-related toxicant exposure
Time frame: End of Week 3, End of Week 6
Reduction in numeric expired air CO readings
3 secondary outcomes
Change in self-reported cigarette consumption
Time frame: End of Week 3, End of Week 6
CO-verified smoking abstinence
Time frame: End of Week 3, End of Week 6
Number of cigarettes smoked
Time frame: End of Week 3, End of Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 38905632Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Cheng, PhD principal investigator
ALCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), Access to Original on! 4mg nicotine pouches and Non-Flavored then complete flavor on! nicotine pouches in people with Cigarette Smoking Behavior, run by Altria Client Services LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Cheng, PhD (5175998785, hui.cheng@altria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cigarette-related toxicant exposure (time frame: End of Week 3, End of Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.