Smoking CessationNCT01497158
Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults
A study testing Self-help brochure and Biomarker feedback in people with Smoking Cessation and Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Self-help brochure and Biomarker feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Cohabitating Non-Smoker (control) and smoker (active)
- Smoker must test > 6ppm on carbon dioxide (CO) test and non-smoker < 6ppm
- General good health
- Written informed consent
- Live within Twin Cities 7 county metropolitan area (Minnesota)
- Plan to live in same home for 6 months and be willing for researchers to come to their home
Who cannot join
- Individuals that live in a treatment facility or shelter
- Individuals endorsing current domestic violence
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455'
About this study
Official title: Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults
This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.
Read the detailed description
This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- Self-help brochure, Biomarker feedback
- Keywords
- tobacco cessation
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help brochureOther
Self help brochure given at baseline visit.
Biomarker feedbackOther
Biomarker feedback from urine of adult non-smoker in the home.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home. Receives: Other: Self-help brochure |
| Active Group | Active comparator | Participants who received self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home and biomarker feedback from the urine of cohabitating adult non-smoker in the home. Receives: Other: Self-help brochure; Other: Biomarker feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling
Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
Measured: From baseline to week 12
Comparison of Self-Reported Home Smoking Restrictions - Control Group
Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startJun 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet Thomas, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497158
- Sponsor's protocol ID
- 2007NT053
- Status last verified
- Aug 2014
- First submitted
- 20 Dec 2011
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Home Smoking Restrictions: Biomarker Feedback to Cohabitating Smoking and Non-Smoking Adults
- ClinicalTrials.gov ID
- NCT01497158
- Acronym / sponsor ID
- 2007NT053
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- tobacco cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Dec 2011 (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.
This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.
Detailed description
This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Self-help brochureParticipants who received only self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home. |
| Active Group | Active comparator | Other: Self-help brochure, Other: Biomarker feedbackParticipants who received self-help brochure regarding environmental tobacco smoking (ETS) exposure in the home and biomarker feedback from the urine of cohabitating adult non-smoker in the home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be at least 18 years of age
- Cohabitating Non-Smoker (control) and smoker (active)
- Smoker must test > 6ppm on carbon dioxide (CO) test and non-smoker < 6ppm
- General good health
- Written informed consent
Key exclusion criteria (2 listed)
- Individuals that live in a treatment facility or shelter
- Individuals endorsing current domestic violence
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 |
|---|---|---|
| Self-help brochureSelf help brochure given at baseline visit. | Other | Active Group, Control Group |
| Biomarker feedbackBiomarker feedback from urine of adult non-smoker in the home. | Other | Active Group |
Primary outcome
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling
Time frame: From baseline to week 12
Received self-help brochure and biomarker feedback from urine collected from non-smoking adult in home. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
Comparison of Self-Reported Home Smoking Restrictions - Control Group
Time frame: From baseline to week 12
Received only self-help brochure on home ETS exposure. Outcome criteria categorized into 3 areas: establishment of a complete ban (defined as no one allowed to smoke anywhere, ever), some restrictions (smoking allowed in some places or some time), and no restrictions (smoking permitted anywhere, no rules).
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 22 Aug 2014.
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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.
Janet Thomas, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help brochure and Biomarker feedback in people with Smoking Cessation and Tobacco Use Disorder, run by University of Minnesota 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 7 inclusion and 2 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 22 Aug 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.
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?
Comparison of Self-Reported Home Smoking Restrictions - Active Counseling (time frame: From baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2014.