Safety and Efficacy Study of the NRT CQSS2 System for Smoking Cessation in Treatment-Seeking Subjects
Status:
Completed
Trial end date:
2017-10-31
Target enrollment:
Participant gender:
Summary
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to
deliver nicotine into the systemic circulation via the skin. They have been found to reduce
craving, thereby enhancing a patient's success for quitting smoking. However, side effects
such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are
commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an
innovative programmable transdermal drug delivery system called the Chrono Quit Smoking
Solution (CQSS2) that provides "off" periods (periods in which little to no nicotine is
delivered), which is an advantage over existing systems that currently provide continuous
delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus
the reduced side effects of sleep disturbances and potentially, skin irritation. The period
when less nicotine is being delivered through the skin allows the skin an opportunity to
"recover", thereby potentially reducing skin irritation. Another major benefit is the
automatic dosing, which provides higher drug dosage at specific times of the day, leading to
potentially greater success in quitting smoking. In this study, the CQSS2 will be used in
conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile
app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach
comprise the CQSS2 System.