Oral Nicotine Products for Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different oral nicotine products to assess their effects on cravings and the body's response in people who smoke. Researchers aim to compare these products to regular smoking in terms of satisfaction and nicotine levels in the blood. Smokers who have used cigarettes as their main source of tobacco for at least six months and smoke at least 10 cigarettes a day might be suitable for this study. Participants will try a range of products and must be comfortable staying in a clinic for a few days. As an unphased trial, this study offers a unique opportunity to explore new ways to manage cravings and improve health.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must not use any medication or substance that helps with smoking cessation within 30 days before the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that oral nicotine products, like those in this study, have undergone safety checks. The FDA has approved several nicotine pouch products after careful review, indicating they are generally considered safe to use, though they carry risks.
Studies have shown that these nicotine pouches are less harmful than regular tobacco products because they don't contain tobacco. However, they can still pose risks, particularly to heart health, and some individuals might experience effects on their heart health.
No nicotine product is completely risk-free. While these products might be safer than smoking, they can still cause side effects. Prospective participants should weigh the pros and cons before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these oral nicotine products because they offer a potentially safer and more controlled way to help smokers quit compared to traditional methods like nicotine patches, gum, or lozenges. These products are distinctive because they are designed to deliver nicotine orally, which may satisfy cravings more quickly and mimic the hand-to-mouth action of smoking, a crucial aspect for many trying to quit. Additionally, the variety of products being tested could provide tailored options to better suit individual needs, increasing the likelihood of successful smoking cessation.
What evidence suggests that this trial's treatments could be effective for smoking?
Research has shown that oral nicotine products can help people smoke fewer cigarettes and reduce their dependence over several weeks. However, whether people can completely switch from traditional cigarettes to these products remains unclear. In this trial, participants will use different sequences of products. Studies have found that nicotine pouches, such as Products A, B, C, D, F, and N, might not be as effective as e-cigarettes for quitting smoking. Product E, which resembles e-cigarettes, proved more effective for quitting smoking than other nicotine replacement therapies. While these products seem promising for reducing smoking, their overall effectiveness for quitting is still under investigation.678910
Who Is on the Research Team?
Brian Keyser
Principal Investigator
Reynolds American
Are You a Good Fit for This Trial?
This trial is for generally healthy smokers aged 21-60 who smoke at least 10 cigarettes a day and have done so for the past 6 months. They must be able to understand English, sign consent forms, and complete questionnaires. Participants should use their usual brand of cigarette throughout the study and can also be users of smokeless tobacco products.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Confinement
Participants are confined for 6 days to evaluate abuse liability of nicotine products
Test Sessions
Participants undergo four test sessions to evaluate different nicotine products
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Product A
- Product B
- Product C
- Product D
- Product E
- Product F
- Product N
Trial Overview
The study is testing five modern oral nicotine products (Product A, E, N, D, C, F, B) to assess their potential for abuse. It's an open-label study where participants will try different products in random order across two sites to measure subjective effects and physiological responses.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Enrolled subjects will be randomized to one of four product use sequences, such that one of the four IPs (A, E, F, N) will be used in each of the four test sessions.
Enrolled subjects will be randomized to one of four product use sequences, such that one of the four IPs (A, B, C, D) will be used in each of the four test sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
RAI Services Company
Lead Sponsor
Citations
Oral nicotine pouches for cessation or reduction of use of ...
Low‐certainty evidence suggests that people randomised to ONP may be slightly less likely to quit smoking than those randomised to e‐cigarettes, ...
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tobaccopreventioncessation.com
tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.htmlThe effectiveness of nicotine replacement therapy on oral ...
Conclusions: NRT can aid in OST cessation. Combination of NRT with other interventions such as coach calls and web-based interactive setting can ...
Can Nicotine Pouches Help People Quit Smoking?
The idea of using alternative products to quit smoking isn't new: e-cigarettes have been shown to be more effective than NRT for smoking ...
Nicotine pouches and clinical outcomes related to smoking ...
While pilot trial data suggest that NPs can help reduce cigarette consumption and dependence over several weeks, full switching from cigarettes ...
Can oral tobacco and nicotine products help people to ...
Overall, it is currently unclear whether oral tobacco and oral nicotine products improve the likelihood of smoking cessation.
FDA Authorizes Marketing of 20 ZYN Nicotine Pouch ...
The US Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway.
The New Nicotine Pouch Category: A Tobacco Harm ...
Examples of new product categories are electronic cigarettes, heat-not-burn products, and nicotine pouches (NP). This commentary discusses the oral NP category.
Impact of Smokeless Oral Nicotine Products on ...
Smokeless oral nicotine products are addictive, and their use has potential adverse effects on some but not all biomarkers of cardiovascular risk.
Nicotine Pouches | Smoking and Tobacco Use
Get the facts about nicotine pouches and their health effects. The bottom line. There are no safe tobacco products, including nicotine pouches.
The safety of using oral nicotine pouches
The lack of tobacco is likely to ensure ONP has a lower risk profile than snus [6]. Determining whether to feel excited or sceptical about the ...
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