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OpenTrials
Completed

NCT Number: NCT00715871

Clinical Study of Smoke-Break Liquid Cigarettes

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.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tommy G. Thompson Youth Center

West Allis, Wisconsin, 53214, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicotine

Drug

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 names: Smoke-Break, liquid cigarette, liquid nicotine cigarette

Smoke-Break nicotine delivery device

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 names: Smoke-Break, liquid cigarette, liquid nicotine cigarette

Primary outcomes

  1. Smoke cessation

    Time frame: 12 weeks

Secondary outcomes

  1. Side effects

    Time frame: 0-12 weeks

Sponsors and collaborators

Lead sponsor

Smoke-Break, Inc.

Industry

Registry information

Official study title

Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2008
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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