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Clinical Study of Smoke-Break Liquid Cigarettes
This study has been completed.
Sponsor:
Smoke-Break, Inc.
Information provided by (Responsible Party):
Smoke-Break, Inc.
ClinicalTrials.gov Identifier:
NCT00715871
First received: July 8, 2008
Last updated: November 17, 2014
Last verified: November 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Smoking | Drug: Nicotine Device: Smoke-Break nicotine delivery device | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device |
Resource links provided by NLM:
Further study details as provided by Smoke-Break, Inc.:
Primary Outcome Measures:
- Smoke cessation [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- Side effects [ Time Frame: 0-12 weeks ]
| Enrollment: | 52 |
| Study Start Date: | February 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Smoke-Break, liquid cigarette, liquid nicotine cigarette
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715871
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715871
Locations
| United States, Wisconsin | |
| Tommy G. Thompson Youth Center | |
| West Allis, Wisconsin, United States, 53214 | |
Sponsors and Collaborators
Smoke-Break, Inc.
Investigators
| Principal Investigator: | Nicholas Geimer, MD | Smoke-Break, Inc. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Smoke-Break, Inc. |
| ClinicalTrials.gov Identifier: | NCT00715871 History of Changes |
| Other Study ID Numbers: |
SB07211 |
| Study First Received: | July 8, 2008 |
| Last Updated: | November 17, 2014 |
Keywords provided by Smoke-Break, Inc.:
|
smoking smoke cessation stop smoking quit smoking |
nicotine replacement therapy Smoke Break liquid cigarette liquid nicotine cigarette |
Additional relevant MeSH terms:
|
Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 24, 2017