Clinical Study of Smoke-Break Liquid Cigarettes

November 17, 2014 updated by: Smoke-Break, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • West Allis, Wisconsin, United States, 53214
        • Tommy G. Thompson Youth Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Smokers
Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes.
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.
Other Names:
  • Smoke-Break, liquid cigarette, liquid nicotine cigarette
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.
Other Names:
  • Smoke-Break, liquid cigarette, liquid nicotine cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Smoke cessation
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 0-12 weeks
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smoke-Break, Inc.

Investigators

  • Principal Investigator: Nicholas Geimer, MD, Smoke-Break, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 12, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB07211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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