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Clinical Study of Smoke-Break Liquid Cigarettes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smoke-Break, Inc.
ClinicalTrials.gov Identifier:
NCT00715871
First received: July 8, 2008
Last updated: November 17, 2014
Last verified: November 2014
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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)
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
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

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

Responsible Party: Smoke-Break, Inc.
ClinicalTrials.gov Identifier: NCT00715871     History of Changes
Other Study ID Numbers: SB07211 
Study First Received: July 8, 2008
Last Updated: November 17, 2014
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
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

ClinicalTrials.gov processed this record on September 27, 2016