At a glance
ClinicalIndex Comparison Record- ✓Current daily user of banned flavored ENDS (fruit, candy, dessert) for past 6 months
- ✓No tobacco or smokeless tobacco use for past 6 months
- ✓No acute respiratory illness within 30 days before enrollment
- ✓Must not want to quit vaping or stop using flavored product for next 90 days after receiving information about flavor ban
- ✕Health conditions affecting immune responses or inflammatory markers: allergic rhinitis, asthma, immunodeficiency (HIV), Guillain-Barré Syndrome, COPD
- ✕Fever or respiratory illness within 30 days before entry
- ✕Pregnant or nursing
- ✕History of serious side effects from nicotine or nicotine replacement therapies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel-group Open-label Trial of ENDS Users Switching From Flavors of Potentially High-toxicity Profile to Flavors of Potentially Low-toxicity Profile (CRoFT_3.2)
In Brief
A clinical study evaluating E-cigarette Flavor and Tobacco Free Nicotine Pouch for Electronic Cigarette Use. Completed, enrolled 163 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Participants will use their current flavor of e cigarettes for 90 days
Participants will use a new assigned flavor for 90 days
Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.
Interventions
Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
participants will use tobacco free oral nicotine pouches