Flavors and Cooling Agents in Nicotine Pouches
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different flavors and cooling sensations in oral nicotine pouches affect user preferences and perceptions. It tests various nicotine pouch types, including those with menthol, synthetic cooling agents, and flavors like peppermint. The goal is to understand how these characteristics might help smokers switch to less harmful alternatives and guide future regulations. Smokers who have smoked at least 100 cigarettes and currently smoke five or more per day might be a good fit.
As an unphased trial, this study allows participants to contribute to important research that could shape future smoking cessation options.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must abstain from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nicotine pouches, like those used in this study, present some known safety concerns. Users have reported side effects such as nausea, gum pain, and mouth sores. These pouches can also increase heart rate and cause irritation. Although they do not contain tobacco, they do contain nicotine, which is addictive and can impact heart and oral health.
For the "Chill" pouches, which include a synthetic cooling ingredient called WS-3, detailed safety information is limited. However, these cooling ingredients are generally considered safe in food, suggesting they might not introduce additional risks beyond those of nicotine itself.
All these pouches are based on nicotine, so they carry risks similar to other nicotine products, including addiction and effects on oral health. Despite being marketed as a safer option for smokers, they still pose risks. Pregnant women, young adults, and youth should avoid them due to nicotine's harmful effects.12345Why are researchers excited about this trial?
Researchers are excited about the use of flavors and cooling agents in nicotine pouches because they offer a unique approach to enhancing user experience without the harmful effects of smoking. Unlike traditional smoking cessation aids that often rely on nicotine replacement alone, these pouches incorporate flavors like Smooth, Chill, Menthol, and Peppermint, which may make the transition away from cigarettes more appealing. The addition of cooling agents, such as WS-3, provides a novel sensory experience that could enhance satisfaction and reduce the craving for traditional cigarettes. This innovative approach might offer a more effective and enjoyable way to reduce smoking, potentially leading to higher success rates in quitting smoking.
What evidence suggests that this trial's treatments could be effective?
This trial will compare various flavors and cooling agents in oral nicotine pouches (ONPs) to assess their appeal and effectiveness in helping people reduce smoking. Research has shown that flavored pouches, such as mint or menthol, are generally more appealing than plain ones. Menthol is particularly popular for its strong sensory experience, which can ease the transition from smoking. In this trial, participants may receive Chill-flavored pouches, which use a synthetic cooling agent called WS-3. This agent provides a cooling sensation without a specific taste, making them suitable in areas where flavored products are banned. These pouches, labeled as "Flavor-Ban Approved," can reduce irritation while still feeling refreshing. Overall, these features might help smokers reduce or quit smoking by offering a satisfying alternative.678910
Who Is on the Research Team?
Brittney L Keller-Hamilton, PhD, MPH
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals who currently smoke cigarettes and are interested in exploring oral nicotine pouches (ONPs) as an alternative. Participants will be asked to use ONPs with different flavors and cooling agents, then provide feedback through questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants sample four randomly-ordered ONPs with different flavors and complete questionnaires assessing product appeal, sensory ratings, and a tobacco purchase task
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Flavors and Cooling Agents in Oral Nicotine Pouches
Trial Overview
The study aims to compare user preferences for various flavors and synthetic cooling agents in ONPs versus their usual cigarette brand. It involves using ONPs, completing questionnaires, and measuring carbon monoxide levels after smoking.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Citations
Studying Flavors and Cooling Agents in Oral Nicotine ...
This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how these ...
2.
ctv.veeva.com
ctv.veeva.com/study/studying-flavors-and-cooling-agents-in-oral-nicotine-pouches-to-understand-user-preferencesStudying Flavors and Cooling Agents in Oral Nicotine ...
This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how ...
Effects of flavour and modified risk claims on nicotine ...
The study found that flavor and modified risk claims had main effects on nicotine pouch appeal and use intentions, but no interaction effect ...
Synthetic cooling agent in oral nicotine pouch products ...
Zyn Chill ONP uses WS-3, an odourless synthetic cooling agent, to provide a cooling sensation, despite being marketed as 'Flavour-Ban Approved'.
Synthetic Cooling Agent in Oral Nicotine Pouch Products ...
Synthetic cooling agents such as WS-3 found in 'Flavor-Ban Approved' Zyn-“Chill” can provide a robust cooling sensation with reduced sensory irritancy.
Nicotine Pouches | Smoking and Tobacco Use
Nicotine is a highly addictive chemical that is especially dangerous for youth, young adults, and pregnant women.
Nicotine Pouches: Use, Benefits, and Risks
Nicotine Pouch Side Effects · Cancers of the mouth, throat, and pancreas · Gum disease · Tooth loss · Cavities and stained teeth · Higher chances of ...
FDA Authorizes Marketing of 20 ZYN Nicotine Pouch ...
As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing ...
What Parents Should Know About Nicotine Pouches
These pouches do not contain tobacco, the plant—and known carcinogen—used in cigarettes and smokeless tobacco, which includes chew and dip. But ...
10.
scientificamerican.com
scientificamerican.com/article/the-health-effects-of-fda-authorized-zyn-nicotine-pouches/The Health Effects of FDA-Authorized ZYN Nicotine Pouches
Like any nicotine product, the pouches can have short-term side effects such as elevated heart rate, irritation and nausea. The small packets ...
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