Clinical Study of Smoke-Break Liquid Cigarettes

Smoke-Break

Status and phase

Completed

Phase 2

Conditions

Smoking

Treatments

Device: Smoke-Break nicotine delivery device

Drug: Nicotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00715871

SB07211

Details and patient eligibility

About

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.

Full description

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

Enrollment

52 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.