Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2008-02-29
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active Smokers
Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.
Nicotine
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.
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.
Interventions
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Nicotine
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteer currently smokes cigarettes, cigars or other forms of tobacco products for at least one year.
* Volunteer wants to quit smoking.
* Volunteer will be fully informed as to the nature of the study.
* Volunteer will have no known allergy to any product ingredients as listed in the informed consent.
* Volunteer agrees to a confidential pretest questionnaire and periodic monitoring as to the effectiveness of the smoking cessation regimen.
* Volunteers are not currently using another nicotine replacement therapy.
* Volunteer will agree to use birth control measures while on the study.
Exclusion Criteria
* Volunteer does not desire to quit smoking.
* Volunteer is using another nicotine replacement therapy.
* Volunteer is pregnant or breast-feeding.
* Volunteer has a history of heart disease or advanced diabetes.
* Volunteer indicates on the application that they smoke ten (10) or fewer cigarettes per day.
* Volunteer is using a daily prescription medicine for depression or asthma.
* Volunteer is using a non-nicotine smoke cessation drug, such as Zyban or Chantix.
* Volunteer is an employee of Smoke-Break Inc., or is personally known to an employee of Smoke-Break Inc.
18 Years
70 Years
ALL
No
Sponsors
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Smoke-Break, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Geimer, MD
Role: PRINCIPAL_INVESTIGATOR
Smoke-Break, Inc.
Locations
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Tommy G. Thompson Youth Center
West Allis, Wisconsin, United States
Countries
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References
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Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health. 2010 Mar 24;10:155. doi: 10.1186/1471-2458-10-155.
Other Identifiers
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SB07211
Identifier Type: -
Identifier Source: org_study_id