E-cigarettes vs Nicotine Pouches for Smoking Cessation
Recruiting in Palo Alto (17 mi)
Overseen ByLisa Fucito, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must not be taking: NRT, Bupropion, Varenicline
Disqualifiers: Pregnancy, Breastfeeding, Medical, Psychiatric, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be using smoking cessation medications like nicotine replacement therapy, bupropion, or varenicline.
What data supports the effectiveness of the treatment E-cigarettes and Nicotine Pouches for smoking cessation?
Research suggests that e-cigarettes can be effective for helping people quit smoking by providing nicotine and mimicking the act of smoking. Nicotine pouches, like ZYN, are considered a lower-risk alternative to smoking, with a toxicant profile similar to Swedish snus, which is known to be less harmful than smoking.
12345Is there any safety information available for e-cigarettes and nicotine pouches?
Research suggests that nicotine pouches like Zyn may be a lower-risk alternative to smoking, with a toxicant profile similar to Swedish snus, which is known to be less harmful than smoking. However, there is limited research on their safety, and more studies are needed to fully understand their potential harms and benefits.
12678How do e-cigarettes and nicotine pouches differ from other treatments for smoking cessation?
E-cigarettes and nicotine pouches are unique smoking cessation aids because they provide both nicotine and a behavioral substitute for smoking, unlike traditional nicotine replacement therapies (NRTs) that only deliver nicotine. Nicotine pouches are tobacco-free and offer a reduced-risk alternative to cigarettes, similar to Swedish snus, with potentially lower health risks.
124910Eligibility Criteria
Adults over 21 who currently smoke cigarettes and are willing to try e-cigarettes or nicotine pouches. They must speak English, not be planning to quit smoking or use cessation drugs in the next month, and cannot be pregnant, breastfeeding, using other cessation services, or have a serious medical condition or allergy to propylene glycol.Inclusion Criteria
I am over 21 years old.
English literate
You are actively smoking cigarettes, as confirmed by biochemistry.
+1 more
Exclusion Criteria
Currently pregnant or breastfeeding
Known hypersensitivity to propylene glycol.
I am currently using help or medication to quit smoking.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either e-cigarettes or nicotine pouches for 4 weeks, with bi-weekly research visits to complete study measures
4 weeks
5 visits (in-person or remote videocall)
Follow-up
Participants complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products
2 weeks
1 visit (in-person or remote videocall)
Participant Groups
The trial is testing if switching smokers from cigarettes to either e-cigarettes with varying nicotine levels and flavors (tobacco only or menthol) or flavored tobacco pouches with different nicotine strengths can reduce cigarette smoking over a period of 4 weeks.
2Treatment groups
Experimental Treatment
Group I: Nicotine PouchesExperimental Treatment4 Interventions
Adults who smoke cigarettes will be randomized to receive nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (6mg pouch) or lower (3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.
Group II: E-cigarettesExperimental Treatment4 Interventions
Adults who smoke cigarettes will be randomized to receive e-cigarettes for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig) or lower (2.4% e-cig). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.
E-cigarettes is already approved in European Union, United States, Canada, Japan, United Kingdom for the following indications:
🇪🇺 Approved in European Union as E-cigarettes for:
- Smoking cessation aid
🇺🇸 Approved in United States as E-cigarettes for:
- No therapeutic indications approved; regulated as tobacco products
🇨🇦 Approved in Canada as E-cigarettes for:
- Smoking cessation aid under prescription
🇯🇵 Approved in Japan as E-cigarettes for:
- Prescription-only for smoking cessation
🇬🇧 Approved in United Kingdom as E-cigarettes for:
- Smoking cessation aid under prescription
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
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]Tobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published.
Estimating the public health impact had tobacco-free nicotine pouches been introduced into the US in 2000. [2022]For smokers not intending to quit, switching to a reduced-risk nicotine product should be healthier than continuing smoking. We estimate the health impact, over the period 2000-2050, had the nicotine pouch ZYN hypothetically been introduced into the US in 2000. ZYN's toxicant profile and method of use is like that for Swedish snus, a product with known health effects much less than smoking.
Efficacy of electronic cigarettes for smoking cessation. [2018]To review data demonstrating effective smoking cessation with electronic cigarettes (e-cigarettes).
A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. [2023]E-cigarettes, or nicotine vaping products, are potential smoking cessation aids that provide both nicotine and behavioural substitution for combustible cigarette smoking. This review aims to compare the effectiveness of nicotine e-cigarettes for smoking cessation with licensed nicotine replacement therapies (NRT) and nicotine-free based control conditions by using network meta-analysis (NMA).
A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design. [2022]Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using electronic cigarettes (e-cigarettes) to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.
Synthetic cooling agent in oral nicotine pouch products marketed as 'Flavour-Ban Approved'. [2023]US sales of oral nicotine pouches (ONPs) have rapidly increased, with cool/mint-flavoured ONPs the most popular flavour category. Restrictions on sales of flavoured tobacco products have either been implemented or proposed by several US states and localities. Zyn, the most popular ONP brand, is marketing Zyn Chill and Zyn Smooth as 'Flavour-Ban Approved' or 'unflavoured', probably to evade flavour bans and increase product appeal. At present, it is unclear whether these ONPs are indeed free of flavour additives that can impart pleasant sensations such as cooling.
The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? [2023]Nicotine pouches to be put under the upper lip are a new category of products that are being rapidly developed and marketed as consumer goods with little research or regulatory oversight. We have identified research gaps in assessing their harm and benefit potential, and possible regulatory science approaches to inform the policies that can allow a maximization of the category's public health potential while minimizing unintended consequences. Implications: This commentary presents a potential blueprint for a comprehensive assessment of the nicotine pouches category. Data from the proposed research areas can better inform the regulatory policy decisions around the category, with the aim to maximize the category's tobacco harm reduction potential while minimizing unintended harms.
Synthetic Cooling Agent in Oral Nicotine Pouch Products Marketed as "Flavor-Ban Approved". [2023]US sales of oral nicotine pouches (ONPs) have rapidly increased, with cool/mint-flavored ONPs the most popular. Restrictions on sales of flavored tobacco products have either been implemented or proposed by several US states and localities. Zyn, the most popular ONP brand, is marketing Zyn-"Chill" and Zyn-"Smooth" as "Flavor-Ban Approved", probably to evade flavor bans. At present it is unclear whether these ONPs are indeed free of flavor additives that can impart pleasant sensations such as cooling.
E-cigarettes Associated With Depressed Smoking Cessation: A Cross-sectional Study of 28 European Union Countries. [2022]Electronic cigarettes (e-cigarettes) are often promoted to assist with cigarette smoking cessation. In 2016-2017, the relationship between e-cigarette use and having stopped smoking among ever (current and former) smokers was assessed in the European Union and Great Britain by itself.
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]Oral nicotine pouches (ONPs) probably offer reduced harm compared with cigarettes, but independent data concerning their misuse liability are lacking. We compared nicotine delivery and craving relief from ONPs with different nicotine concentrations to cigarettes.