Clinical Study of Smoke-Break Liquid Cigarettes

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Smoke-Break, Inc.
• Treatments: Nicotine

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.