Clinical Study of Smoke-Break Liquid Cigarettes

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715871
• Other study ID #: SB07211
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2008
• Last updated: November 17, 2014
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: November 2014
• Source: Smoke-Break, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Tommy G. Thompson Youth Center	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Smoke-Break, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoke cessation		12 weeks	No
Secondary	Side effects		0-12 weeks	Yes