400 Participants Needed

Flavored Nicotine Pouches for Smoking Reduction

HC
Overseen ByHui Cheng, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking psychoactive medications like antipsychotics or mood stabilizers.

Is it safe to use flavored nicotine pouches for smoking reduction?

Research suggests that flavored nicotine pouches might be a lower-risk alternative to smoking cigarettes, but there is limited data on their safety. More studies are needed to fully understand their potential harms and benefits.12345

How do flavored on!® nicotine pouches differ from other smoking reduction treatments?

Flavored on!® nicotine pouches are unique because they are tobacco-free, oral products that come in various flavors and nicotine strengths, offering a potentially lower-risk alternative to traditional cigarettes and tobacco-based products. Unlike other smoking reduction treatments, these pouches do not contain tobacco leaves and are designed to reduce harm for smokers who cannot or do not want to quit smoking entirely.13567

What data supports the effectiveness of the treatment Flavored on!® Nicotine Pouch Products for smoking reduction?

Research suggests that switching from cigarettes to flavored nicotine pouches may reduce harm for smokers who can't or don't want to quit smoking. Flavored nicotine pouches are popular among young adults and may encourage smokers to switch from cigarettes to these pouches.36789

Who Is on the Research Team?

HC

Hui Cheng, PhD

Principal Investigator

ALCS

Are You a Good Fit for This Trial?

Adults aged 22-65 who smoke at least 5 cigarettes daily for the past year, want to switch to a smoke-free tobacco product, and can use a smartphone with text and data. Excluded are those in poor health or with certain medical conditions, involved in tobacco litigation or industry, pregnant/nursing women not using birth control, heavy marijuana users, and recent participants in other tobacco studies.

Inclusion Criteria

I do not plan to use FDA-approved nicotine treatments soon.
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.
See 4 more

Exclusion Criteria

I cannot read, speak, or understand English.
I have used or am using nicotine pouch products.
I am taking medication for mental health issues.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline

Participants are followed for 3-7 days to establish baseline measures of cigarettes smoked per day, with at least two CO readings collected

1 week
Daily surveys

Treatment

Participants use research products for 6 weeks, with different access to flavors based on group assignment

6 weeks
Weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-month follow-up survey

6 months
1 survey (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Flavored on!® Nicotine Pouch Products
Trial Overview The trial is testing if flavored nicotine pouches (Berry, Citrus, Cinnamon etc.) help smokers reduce cigarette use more than non-flavored pouches over six weeks. Participants will be given these products to see if flavors lead to greater smoking reduction compared to just the Original flavor.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Complete flavor profile of on! nicotine pouchesExperimental Treatment1 Intervention
Group II: Non-Flavored then complete flavor on! nicotine pouchesActive Control1 Intervention
Group III: Non-Flavored on! nicotine pouches onlyActive Control1 Intervention

Flavored on!® Nicotine Pouch Products is already approved in United States, Canada, United Kingdom for the following indications:

🇺🇸
Approved in United States as on! for:
🇨🇦
Approved in Canada as Zonnic Nicotine Pouches for:
🇬🇧
Approved in United Kingdom as Nicotine Pouches for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Altria Client Services LLC

Lead Sponsor

Trials
10
Recruited
1,900+

Rose Research Center, LLC

Industry Sponsor

Trials
17
Recruited
1,600+

Published Research Related to This Trial

In a study involving adult smokers, nicotine pouches (NPs) showed lower peak nicotine levels (Cmax) and longer time to peak (tmax) compared to traditional cigarettes, indicating a slower nicotine delivery.
Participants reported lower cravings for cigarettes when using NPs, suggesting that these products may have a lower abuse potential and could serve as a safer alternative for smokers looking to switch from cigarettes.
Nicotine pharmacokinetics and subjective response among adult smokers using different flavors of on!® nicotine pouches compared to combustible cigarettes.Rensch, J., Liu, J., Wang, J., et al.[2021]
Adult tobacco users perceive oral nicotine pouches (ONPs) as significantly less harmful and less addictive compared to non-users, indicating a potential misperception of risk among users.
The displayed nicotine concentration on ONP packaging significantly influences perceptions of harm and addictiveness, with higher concentrations leading to lower perceived risks, suggesting that packaging features could impact public health perceptions.
The Effects of Oral Nicotine Pouch Packaging Features on Adult Tobacco Users' and Non-Users' Product Perceptions.Mays, D., Long, L., Alalwan, MA., et al.[2023]
In a study involving 30 adult smokers, 6-mg oral nicotine pouches (ONPs) delivered more nicotine to the bloodstream at 30 minutes compared to both 3-mg ONPs and cigarettes, suggesting they can be effective for nicotine delivery.
However, neither concentration of ONPs provided as much relief from cravings at 5 minutes as cigarettes did, indicating that while ONPs may be less harmful, they might not satisfy cravings as effectively, which could influence their potential for misuse.
Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study.Keller-Hamilton, B., Alalwan, MA., Curran, H., et al.[2023]

Citations

Nicotine pharmacokinetics and subjective response among adult smokers using different flavors of on!® nicotine pouches compared to combustible cigarettes. [2021]
The Effects of Oral Nicotine Pouch Packaging Features on Adult Tobacco Users' and Non-Users' Product Perceptions. [2023]
Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. [2023]
Classification, Perception, and Toxicity of Emerging Flavored Oral Nicotine Pouches. [2023]
Perceptions of Oral Nicotine Pouches on Reddit: Observational Study. [2022]
Nicotine pouch product awareness, interest and ever use among US adults who smoke, 2021. [2023]
Tobacco-free Nicotine Pouch Use in Great Britain: A Representative Population Survey 2020-2021. [2022]
The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? [2023]
Harmful and potentially harmful constituents (HPHCs) in two novel nicotine pouch products in comparison with regular smokeless tobacco products and pharmaceutical nicotine replacement therapy products (NRTs). [2023]
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