Clinical Study of Smoke-Break Liquid Cigarettes
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|ClinicalTrials.gov Identifier: NCT00715871|
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: Nicotine Device: Smoke-Break nicotine delivery device||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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
- Smoke cessation [ Time Frame: 12 weeks ]
- Side effects [ Time Frame: 0-12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715871
|United States, Wisconsin|
|Tommy G. Thompson Youth Center|
|West Allis, Wisconsin, United States, 53214|
|Principal Investigator:||Nicholas Geimer, MD||Smoke-Break, Inc.|