Clinical Study of Smoke-Break Liquid Cigarettes - Full Text View

Sponsor:	Smoke-Break, Inc.
Information provided by:	Smoke-Break, Inc.
ClinicalTrials.gov Identifier:	NCT00715871

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: 0-12 weeks ] [ Designated as safety issue: Yes ]

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)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Smoke-Break Inc. ( Nicholas Geimer, MD/Principal Investigator )
Study ID Numbers:	SB07211
Study First Received:	July 8, 2008
Last Updated:	July 12, 2008
ClinicalTrials.gov Identifier:	NCT00715871 History of Changes
Health Authority:	United States: Food and Drug Administration

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 polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Cholinergic Agents
Pharmacologic Actions

Smoking
Habits
Nicotine
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010