E-Cigarette Flavors for Vaping-Related Respiratory Symptoms
(CRoFT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have health conditions or are on therapies that affect immune responses, you may be excluded from the trial.
What safety data exists for e-cigarette flavors and related products?
Existing safety data for e-cigarette flavors and related products, such as ENDS and nicotine pouches, highlight several concerns. Studies have noted the potential for overheating, fires, and explosions with ENDS devices. There are also reports of acute adverse events from liquid nicotine exposure, particularly in young children. Additionally, there is a lack of comprehensive research and regulatory oversight for nicotine pouches, indicating a need for further study to assess their harm and benefit potential.12345
Is the treatment E-cigarette Flavor, Tobacco Free Nicotine Pouch a promising treatment for vaping-related respiratory symptoms?
What data supports the idea that E-Cigarette Flavors for Vaping-Related Respiratory Symptoms is an effective treatment?
The available research does not provide data supporting the idea that E-Cigarette Flavors for Vaping-Related Respiratory Symptoms is an effective treatment. Instead, the studies focus on the safety, regulatory challenges, and potential health risks associated with using flavored electronic nicotine delivery systems (ENDS). For example, one study found a significant association between ENDS use and chronic obstructive pulmonary disease (COPD), suggesting potential health risks rather than benefits. Therefore, there is no evidence from the provided research that supports the effectiveness of this treatment for respiratory symptoms.1261112
Who Is on the Research Team?
Maciej Goniewicz, PhD
Principal Investigator
Roswell Park
Are You a Good Fit for This Trial?
This trial is for adults who've been using electronic nicotine delivery systems (ENDS) with banned flavors like fruit or candy daily for the past 6 months and don't plan to quit soon. They shouldn't have smoked tobacco or used smokeless tobacco in the last 6 months, must be free of respiratory illness for a month before joining, and can't have health conditions affecting immune responses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants switch from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- E-cigarette Flavor
- Tobacco Free Nicotine Pouch
E-cigarette Flavor is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
University of Rochester
Collaborator
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator