SmokingNCT02143752
Meriter Mindfulness Training for Smokers Program and Study
An observational study of Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Mindfulness and Quit Line
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be drawn from the Meriter Smoking Cessation Program, which is made up of two interventions: the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention
Who may be able to join
- everyday smoker
Who cannot join
- current alcohol or other drug addiction
Trial locations and contacts
1 site in 1 country.
United States1 site
Meriter Hospital and Medical Clinics
Madison, Wisconsin, 53703
About this study
The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.
Read the detailed description
The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.
MTS: Mindfulness Training for Smokers Intervention. This is the 7-week quit smoking intervention developed by the PI.
QL: Quit Line Intervention. This is a program starting at makes use of the Wisconsin Tobacco Quit Line.
Meriter Smoking Cessation Program: A program offering the MTS and QL interventions to smokers at Meriter Hospital and Clinics.
Meriter Smoking Cessation Study: This is a study comprised of 2 phone surveys and 1 study visit that tests participants in the MTS and QL intervention. Participants in the Meriter Smoking cessation program will have the opportunity to decide if they would like to be in the study.
- Conditions
- Smoking
- Being tested
- Mindfulness, Quit Line
- Keywords
- Smoking, Tobacco, Addiction, Mindfulness, Meditation
- Medical subject headings
- Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called Mindfulness Training for Smokers
Group behavioral intervention using mindfulness to help smokers quit smoking
Quit LineBehavioural
Also called see arm
see arm
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Smokers enter a Mindfulness Training for Smokers course Receives: Behavioral: Mindfulness | |
| Quit Line | Smokers attempt smoking cessation with the help of the Wisconsin Tobacco Quit Line Receives: Behavioral: Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemically confirmed post treatment smoking abstinence
Carbon monoxide levels are obtained 10 days post quit. CO under 7 = abstinence.
Measured: 10 days post quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
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.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James M Davis, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143752
- Sponsor's protocol ID
- 2012-001
- Other IDs
- 2012-001
- Status last verified
- Apr 2015
- First submitted
- 17 Jan 2013
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis JM, Mills DM, Stankevitz KA, Manley AR, Majeskie MR, Smith SS. Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers. BMC Complement Altern Med. 2013 Sep 3;13:215. doi: 10.1186/1472-6882-13-215.
PubMed 24006963
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meriter Mindfulness Training for Smokers Program and Study
- ClinicalTrials.gov ID
- NCT02143752
- Acronym / sponsor ID
- 2012-001
- Conditions
- Smoking
- Keywords
- Smoking, Tobacco, Addiction, Mindfulness, Meditation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 May 2014 (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 Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.
Detailed description
The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.
MTS: Mindfulness Training for Smokers Intervention. This is the 7-week quit smoking intervention developed by the PI.
QL: Quit Line Intervention. This is a program starting at makes use of the Wisconsin Tobacco Quit Line.
Meriter Smoking Cessation Program: A program offering the MTS and QL interventions to smokers at Meriter Hospital and Clinics.
Meriter Smoking Cessation Study: This is a study comprised of 2 phone surveys and 1 study visit that tests participants in the MTS and QL intervention. Participants in the Meriter Smoking cessation program will have the opportunity to decide if they would like to be in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | – | Behavioral: MindfulnessSmokers enter a Mindfulness Training for Smokers course |
| Quit Line | – | Behavioral: Quit LineSmokers attempt smoking cessation with the help of the Wisconsin Tobacco Quit Line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be drawn from the Meriter Smoking Cessation Program, which is made up of two interventions: the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention
Key inclusion criteria (1 listed)
- everyday smoker
Key exclusion criteria (1 listed)
- current alcohol or other drug addiction
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 |
|---|---|---|
| MindfulnessAlso: Mindfulness Training for SmokersGroup behavioral intervention using mindfulness to help smokers quit smoking | Behavioural | Mindfulness |
| Quit LineAlso: see armsee arm | Behavioural | Quit Line |
Primary outcome
biochemically confirmed post treatment smoking abstinence
Time frame: 10 days post quit
Carbon monoxide levels are obtained 10 days post quit. CO under 7 = abstinence.
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 18 Jun 2023.
- Results publication: PubMed 24006963Davis JM, Mills DM, Stankevitz KA, Manley AR, Majeskie MR, Smith SS. Pilot randomized trial on mindfulness training for smokers in young adult binge drinkers. BMC Complement Altern Med. 2013 Sep 3;13:215. doi: 10.1186/1472-6882-13-215.
- Pilot randomized trial on mindfulness training for smokers in young adult binge drinkersLink provided by the sponsor.
Related trials for Smoking
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Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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.
James M Davis, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by University of Wisconsin, Madison 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 1 inclusion and 1 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 18 Jun 2023. 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?
biochemically confirmed post treatment smoking abstinence (time frame: 10 days post quit). 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 NCT02143752, 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 18 Jun 2023.