Electronic Nicotine Delivery System for Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if electronic nicotine delivery systems (ENDS), such as e-cigarettes, can help people quit smoking regular cigarettes. Participants will receive an ENDS device and access to various flavored e-liquids, including tobacco, menthol, or non-tobacco/non-menthol, over a three-month period. The trial suits individuals who have smoked at least 10 cigarettes daily for the past month and are open to trying e-cigarettes. Participants should also have smoked regularly for at least a year. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding alternative smoking cessation methods.
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 cannot participate if you are taking medication for depression.
What prior data suggests that this electronic nicotine delivery system is safe for smoking cessation?
Research shows that electronic nicotine delivery systems (ENDS), like e-cigarettes, carry risks. Studies have found that e-cigarette vapor contains nicotine and tiny particles that can enter the lungs. This vapor may also contain harmful chemicals.
Some reports highlight possible dangers, such as skin irritation and the risk of harm if e-liquids are swallowed or come into contact with the skin. E-liquids can also pose a choking hazard for young children. Although these devices are often seen as safer than regular cigarettes, they are not without risk.
E-cigarettes are regulated by the FDA as alternatives to smoking, meaning they meet certain safety standards but still carry some risks. When considering participation in a trial involving these devices, it is important to weigh the benefits of reducing smoking against these potential risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these electronic nicotine delivery systems (ENDS) because they offer customizable flavor options, potentially making them a more appealing alternative to traditional cigarettes for smokers looking to quit. Unlike most standard nicotine replacement therapies, such as patches or gum, which typically lack flavor variety, these systems provide choices like tobacco, menthol, and non-tobacco non-menthol flavors, all at a consistent nicotine level of 5%. This flexibility could enhance user satisfaction and adherence, potentially leading to better smoking cessation outcomes.
What evidence suggests that this trial's treatments could be effective for smoking cessation?
This trial will compare different flavor options of electronic nicotine delivery systems (ENDS) to assess their effectiveness in helping participants reduce or quit smoking. Research has shown that e-cigarettes, a type of ENDS, can assist people in cutting down or quitting regular cigarettes. Studies have found that e-cigarettes usually contain fewer harmful chemicals than traditional cigarettes. Some users have reported fewer harmful changes in their mouths, suggesting lower health risks. While evidence on quitting smoking with e-cigarettes remains mixed, many people find them useful for reducing smoking. Overall, e-cigarettes might be a less harmful option than smoking, with some potential to help smokers quit.678910
Who Is on the Research Team?
Melissa Tapia, Ph.D.
Principal Investigator
RAIS Service Co
Are You a Good Fit for This Trial?
This trial is for primary smokers who regularly use combustible cigarettes and are interested in trying to quit by using an electronic nicotine delivery system (ENDS) over a three-month period. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Trial Period
Participants are enrolled, randomized, and begin a one-week trial period to sample available flavors
Treatment
Participants use the electronic nicotine delivery system with varying flavor access over a three-month period
Follow-up
Participants are monitored for abstinence and product use, with data collected via surveys and puffing topography
What Are the Treatments Tested in This Trial?
Interventions
- P2611222
- P2613422
- P2615022
- P2615122
Find a Clinic Near You
Who Is Running the Clinical Trial?
RAI Services Company
Lead Sponsor