Clinical Study of Smoke-Break Liquid Cigarettes

Completed · Phase 2

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT00715871

Run by

Smoke-Break, Inc.

People needed

52

Starts

2008-02-01

Expected to finish

2008-07-01

Last updated by the study team

2014-11-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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