Clinical Study of Smoke-Break Liquid Cigarettes

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: Nicotine; Device: Smoke-Break nicotine delivery device

• Registration Number: NCT00715871
• Lead Sponsor: Smoke-Break, Inc.

Brief 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.

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

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-12
• Study First Posted: 2008-07-15
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Smokers	Smoke-Break nicotine delivery device	Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.
Active Smokers	Nicotine	Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.

Primary Outcome Measures

Name	Time	Method
Smoke cessation	12 weeks

Secondary Outcome Measures

Name	Time	Method
Side effects	0-12 weeks

Trial Locations

Locations (1)

Tommy G. Thompson Youth Center; 🇺🇸 West Allis, Wisconsin, United States