Safety & Efficacy Study of the NRT CQSS2 System for Smoking Cessation in

Status Completed

Clinical Trial 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.

Clinical Trial Description

Study EF2016-003 is a Phase 2, randomized, two-arm, open-label, multicenter efficacy and safety study of the CQSS2 System for smoking cessation over a 6-week treatment period in healthy treatment-seeking subjects who are smokers.

PRIMARY OBJECTIVES:

To evaluate quit rates (continuous abstinence from smoking during the last 4 weeks of treatment [Visit 3 through the end of study treatment]) in smokers (more than 10 cigarettes/day) being treated with the CQSS2 System versus NicoDerm® CQ® patch

SECONDARY OBJECTIVES:

To assess the safety and tolerability of the CQSS2 System ;

Study Design

Related Conditions & MeSH terms

Smoking Cessation

Clinical Trial Details

NCT number	NCT03178422
Study type	Interventional
Source	Chrono Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	August 7, 2017
Completion date	October 31, 2017

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Efficacy Study of the NRT CQSS2 System for Smoking Cessation in Treatment-Seeking Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms