Oral Nicotine Pouches vs Electronic Cigarettes for Smoking

NF
MG
Overseen ByMaciej Goniewicz, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different tobacco users experience oral nicotine products compared to electronic cigarettes. Researchers seek to determine which of these products might be more appealing or satisfying for individuals who smoke cigarettes or use other forms of smokeless tobacco. Participants will try both an oral nicotine pouch and an electronic cigarette to compare their experiences. This trial suits daily smokers or smokeless tobacco users who can refrain from using their regular products for 8-10 hours before study visits. As an unphased trial, it offers participants the opportunity to contribute to important research that could shape future tobacco harm reduction strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must abstain from using cigarettes or smokeless tobacco for 8-10 hours before study visits.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both electronic cigarettes and oral nicotine pouches present safety concerns. Studies have found that electronic cigarettes produce harmful chemicals like formaldehyde, which can damage the lungs. Users might also experience coughing, shortness of breath, and headaches.

Although less information is available for oral nicotine pouches, they also pose risks. Nicotine is highly addictive and can harm unborn babies. Using these pouches might increase heart rate and blood pressure, potentially leading to heart problems.

Neither product is risk-free, and both can negatively affect health. Considering these risks is important when deciding to join a trial involving these products.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to deliver nicotine compared to traditional smoking cessation aids like nicotine patches, gums, or lozenges. Electronic cigarettes and oral nicotine pouches like ZYN provide a unique sensory experience and deliver nicotine differently by mimicking the act of smoking or providing a discreet, smokeless option. This could be appealing to those who miss the ritual of smoking or prefer a less conspicuous way to manage nicotine cravings. These alternatives might help more people transition away from combustible tobacco products by offering customizable and potentially less harmful options.

What evidence suggests that this trial's treatments could be effective for nicotine users?

Research has shown that electronic cigarettes can help people quit smoking more effectively than counseling alone. For example, one study found that individuals using e-cigarettes to quit had higher success rates, with some reporting a 70% success rate when used regularly. In this trial, participants will use electronic cigarettes as one of the treatment options.

Conversely, oral nicotine pouches, also studied in this trial, have been found to help reduce smoking, particularly for those willing to try them. However, some evidence suggests they might not be as effective as e-cigarettes for complete smoking cessation. Despite this, oral nicotine pouches can still help people smoke fewer cigarettes. Overall, both options in this trial have shown promise in helping people cut down or quit smoking.678910

Who Is on the Research Team?

MG

Maciej Goniewicz, PhD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

You smoke more than 5 cigarettes per day for at least 1 year.
Self-report fair or better physical health.
Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide < 10ppm).
See 7 more

Exclusion Criteria

You have experienced severe side effects from nicotine or any nicotine replacement products in the past.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
Nursing female participants.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use oral nicotine products and electronic cigarettes for up to 30 minutes per session

4 weeks
Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants' sensory responses are monitored over an extended period

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic Cigarette
  • Oral Nicotine Pouch
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Order 2 - Electronic Cigarettes and Oral Nicotine productExperimental Treatment2 Interventions
Group II: Order 1 - Oral Nicotine product - ZYN and Electronic CigarettesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Citations

Electronic Nicotine-Delivery Systems for Smoking CessationThe addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking ...
E-cigarettes and smoking cessation in real-world ...Data from the large population-based California Tobacco Surveys, showed that NRT was associated with long-term success in quitting cigarettes when available by ...
Effectiveness of e-cigarettes as aids for smoking cessationOn average, using e-cigarettes for cessation in 2017 did not improve successful quitting or prevent relapse.
Electronic Cigarettes As a Smoking-Cessation ToolThose respondents using e-cigarettes more than 20 times per day had a quit rate of 70.0%. Of respondents who were not smoking at 6 months, 34.3% were not using ...
The Effect of 12-Week e-Cigarette Use on Smoking ...Our results showed that even short-term use of e-cigarettes leads to greater smoking cessation at 52 weeks compared to counseling alone. e-Cigarettes are a ...
Health Effects of Vaping | Smoking and Tobacco UseNo tobacco products, including e-cigarettes, are safe. · Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...
Health Hazards and Complications Associated with Electronic ...In conclusion, ECs are at least as harmful to health as conventional cigarettes and are particularly dangerous because of the risk of explosion. Complications ...
Vaping (E-Cigarettes): What It Is, Side Effects & DangersWhat are the side effects of vaping? · Coughing. · Shortness of breath. · Eye irritation. · Headaches. · Dry and irritated mouth and throat. · Nausea.
Health Risks of E-Cigarettes and VapingE-cigarettes produce a number of dangerous chemicals including acetaldehyde, acrolein, and formaldehyde. These aldehydes can cause lung disease, ...
Adverse effects of electronic cigarettes on human healthHarmful substances are generated during the vaporization, such as formaldehyde. Cellular damages and DNA hypermethylation are also found to be associated with ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security