At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
In Brief
A Phase 2 clinical trial evaluating OB, Sham smoking, and 2 other interventions for Smoking. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.
Study Details
Timeline
Interventions
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)