Clinical Study of Smoke-Break Liquid Cigarettes
The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.
Device: Smoke-Break nicotine delivery device
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device|
- Smoke cessation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: 0-12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Active Smokers
Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.
Subjects received an amount of "liquid nicotine cigarettes" (containing 1.5mg of nicotine each) based on the amount of nicotine the subjects had been receiving from cigarettes. The number of "liquid nicotine cigarettes" received by each subject was reviewed, and adjusted (if necessary), every two weeks for the duration of the 12-week study.
Other Name: Smoke-Break, liquid cigarette, liquid nicotine cigaretteDevice: Smoke-Break nicotine delivery device
The Smoke-Break nicotine delivery device is a "liquid nicotine cigarette" designed to mimic the act of smoking. It is an NRT (nicotine replacement therapy) similar in concept to the nicotine patch, gum, and lozenge, except the nicotine is delivered in a way designed to duplicate the cigarette smoking experience. The Smoke-Break nicotine delivery device is non-invasive.
Other Name: Smoke-Break, liquid cigarette, liquid nicotine cigarette
The study has been completed and published. The published study manuscript can be found here: http://www.biomedcentral.com/1471-2458/10/155
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715871
|United States, Wisconsin|
|Tommy G. Thompson Youth Center|
|West Allis, Wisconsin, United States, 53214|
|Principal Investigator:||Nicholas Geimer, MD||Smoke-Break, Inc.|