SmokingPhase 2NCT00715871
Clinical Study of Smoke-Break Liquid Cigarettes
A Phase 2 study testing Nicotine and Smoke-Break nicotine delivery device in people with Smoking, run by Smoke-Break, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking
- What is being tested?
- Nicotine and Smoke-Break nicotine delivery device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tommy G. Thompson Youth Center
West Allis, Wisconsin, 53214
About this study
Official title: 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.
Read the 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
- Conditions
- Smoking
- Being tested
- Nicotine, Smoke-Break nicotine delivery device
- Keywords
- smoking, smoke cessation, stop smoking, quit smoking, nicotine replacement therapy, Smoke Break, liquid cigarette, liquid nicotine cigarette
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Smoke-Break, liquid cigarette, liquid nicotine cigarette
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.
Smoke-Break nicotine delivery deviceDevice
Also called Smoke-Break, liquid cigarette, liquid nicotine cigarette
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Smokers | Experimental | Active smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes. Receives: Drug: Nicotine; Device: Smoke-Break nicotine delivery device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoke cessation
Measured: 12 weeks
Secondary outcomes (1)
Side effects
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smoke-Break, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Geimer, MD, Principal investigator, Smoke-Break, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715871
- Sponsor's protocol ID
- SB07211
- Status last verified
- Nov 2014
- First submitted
- 8 Jul 2008
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health. 2010 Mar 24;10:155. doi: 10.1186/1471-2458-10-155.
PubMed 20334673
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device
- ClinicalTrials.gov ID
- NCT00715871
- Acronym / sponsor ID
- SB07211
- Conditions
- Smoking
- Keywords
- smoking, smoke cessation, stop smoking, quit smoking, nicotine replacement therapy, Smoke Break, liquid cigarette, liquid nicotine cigarette
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Smoke-Break, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Smokers | Experimental | Drug: Nicotine, Device: Smoke-Break nicotine delivery deviceActive smokers who used the Smoke-Break nicotine delivery device in an attempt to quit smoking cigarettes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: Smoke-Break, liquid cigarette, liquid nicotine cigaretteSubjects 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. | Drug | Active Smokers |
| Smoke-Break nicotine delivery deviceAlso: Smoke-Break, liquid cigarette, liquid nicotine cigaretteThe 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. | Device | Active Smokers |
Primary outcome
Smoke cessation
Time frame: 12 weeks
1 secondary outcome
Side effects
Time frame: 0-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Derived from this study: PubMed 20334673Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health. 2010 Mar 24;10:155. doi: 10.1186/1471-2458-10-155.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Geimer, MD principal investigator
Smoke-Break, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine and Smoke-Break nicotine delivery device in people with Smoking, run by Smoke-Break, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoke cessation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.