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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
Sponsor:
Information provided by (Responsible Party):
Smoke-Break, Inc.

July 8, 2008
July 15, 2008
November 19, 2014
February 2008
July 2008   (Final data collection date for primary outcome measure)
Smoke cessation [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00715871 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: 0-12 weeks ]
Same as current
Not Provided
Not Provided
 
Clinical Study of Smoke-Break Liquid Cigarettes
Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device
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.
The study has been completed and published. The published study manuscript can be found here: http://www.biomedcentral.com/1471-2458/10/155
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Smoking
  • Drug: 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.
    Other Name: Smoke-Break, liquid cigarette, liquid nicotine cigarette
  • Device: 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
Experimental: Active Smokers
Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.
Interventions:
  • Drug: Nicotine
  • Device: Smoke-Break nicotine delivery device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Same as current
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Volunteer is at least 18 years of age.
  • 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 has a known allergy or hypersensitivity to nicotine or other related ingredients as outlined in the informed consent.
  • 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00715871
SB07211
No
Not Provided
Not Provided
Smoke-Break, Inc.
Smoke-Break, Inc.
Not Provided
Principal Investigator: Nicholas Geimer, MD Smoke-Break, Inc.
Smoke-Break, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP