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Clinical Study of Smoke-Break Liquid Cigarettes

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00715871

First Posted: July 15, 2008

Last Update Posted: November 19, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Smoke-Break, Inc.

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: Nicotine Device: Smoke-Break nicotine delivery device	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device

Resource links provided by NLM:

MedlinePlus related topics: Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Smoke-Break, Inc.:

Primary Outcome Measures:

Smoke cessation [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Side effects [ Time Frame: 0-12 weeks ]


Enrollment:	52
Study Start Date:	February 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Smokers Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.	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

Arms

Assigned Interventions

Experimental: Active Smokers

Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.

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

Detailed Description:

The study has been completed and published. The published study manuscript can be found here: http://www.biomedcentral.com/1471-2458/10/155

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Wisconsin
Tommy G. Thompson Youth Center
West Allis, Wisconsin, United States, 53214

Sponsors and Collaborators

Smoke-Break, Inc.

Investigators


Principal Investigator:	Nicholas Geimer, MD	Smoke-Break, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Smoke-Break, Inc.
ClinicalTrials.gov Identifier:	NCT00715871 History of Changes
Other Study ID Numbers:	SB07211
First Submitted:	July 8, 2008
First Posted:	July 15, 2008
Last Update Posted:	November 19, 2014
Last Verified:	November 2014

Keywords provided by Smoke-Break, Inc.:


smoking smoke cessation stop smoking quit smoking	nicotine replacement therapy Smoke Break liquid cigarette liquid nicotine cigarette

Additional relevant MeSH terms:


Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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