Nicotine DependenceMTS2NCT01299909
Study Two on the Effectiveness of Mindfulness Training for Smokers
A study testing Integrated Training for Smokers, Mindfulness Training for Smokers and Quitline in people with Nicotine Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Integrated Training for Smokers, Mindfulness Training for Smokers and Quitline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age: 18 years or over;
- Participants must express "high" motivation to quit smoking
- Participants must express willingness to attend "all" meetings for 2 months
- Smoke 5 or more cigarettes per day
Who cannot join
- Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
- Self report of using chewing tobacco, snuff or cigars in the last week.
- High score on Patient Health Questionnaire Depression Screening Tool for severe depression and suicidal intention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers
The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.
Read the detailed description
The MTS2 Study is funded for through a five-year K23 NIH training grant (appendix) awarded to Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is N=240 adult smokers randomized to study treatments. Based on prior recruitment numbers, it is expected that roughly 50% (120) will choose to be in an intensive intervention and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either MTS (n = 60) or ITS (n=60). MTS is a smoking cessation intervention that provides 8 mindfulness classes over a 6-week period. ITS will provide participants will access to the Freedom From Smoking Online Premium Program (at no cost) plus 8 smoking cessation classes over a 6-week period. Participants who choose to be in a non-intensive intervention (n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line. At the Orientation Meeting, participants who decide to enter the study will be allowed to choose whether they enter an intensive or the non-intensive intervention. Intensive intervention participants will attend an additional meeting called the Introductory Meeting where they are will undergo randomization into either the MTS or ITS. The Introductory Meeting will also provide instruction on the use of nicotine patches, smoking calendars and provide intervention materials. The study employs 3 study assessment visits. Study Visit 1 follows the Orientation Meeting, Study Visit 2 is 4-weeks post-quit, Study Visit 3 is 24-weeks post-quit. All participants will receive 2 weeks of free nicotine patches and $30 for attending each of the two post-quit study visits.
The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be three years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through flyers, television, newspaper and radio advertisements.
The principal hypothesis for the study is that MTS compared to ITS will show significantly higher point prevalent Carbon Monoxide confirmed smoking abstinence rates at 4 and 24 weeks post quit. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life and bio-physiological markers such as weight, breath holding and hair cortisol.
- Conditions
- Nicotine Dependence
- Being tested
- Integrated Training for Smokers, Mindfulness Training for Smokers, Quitline
- Keywords
- Mindfulness Training for Smokers, Smoking, Smoking cessation, Addiction, behavioral intervention, Nicotine, Tobacco, Mindfulness, Meditation, MBSR, Mindfulness Based Stress Reduction, Mindfulness Based Cognitive Therapy, MBCT, Mindfulness Based Relapse Prevention, MBRP, Mindfulness Training, Nicotine Patch, Quit Line, Phone counseling, Freedom from Smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Training for SmokersBehavioural
Also called Control Group, ITS
8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
Mindfulness Training for SmokersBehavioural
Also called Study Group, MTS
8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
QuitlineBehavioural
Also called Non-Randomized, Treatment as Usual
Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training for Smokers | Active comparator | MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches. Receives: Behavioral: Mindfulness Training for Smokers |
| Integrated Training for Smokers | Active comparator | ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches. Receives: Behavioral: Integrated Training for Smokers |
| Quitline | Other | Quitline participants will consist of participants who elect not to participate in the high-intensity treatments (Mindfulness Training for Smokers; Integrated Training for Smokers. This Quitline group is a Non-Randomized, Treatment as Usual group. Receives: Behavioral: Quitline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.
Measured: 24 weeks post quit day
Secondary outcomes (3)
Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report questionnaire that assesses various components of mindfulness. Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome).
More information on the FFMQ is available in the following two articles:
Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., \& Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13(1), 27-45, http://dx.doi.org/10.1177/1073191105283504.
Baer,R. A., Smith,G. T., Lykins, E., Button,D., Krietemeyer, J., Sauer, S., et al. (2008). Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment, 15(3), 329-342, http://dx.doi.org/10.1177/1073191107313003.
Measured: 24 weeks post-quit
Acceptance and Action Questionnaire (AAQ)
The Acceptance and Action Questionnaire (AAQ) is a 9-item self-report measure of experiential avoidance. Each item is rated on a 1 to 7 scale with 1=Never true and 7=Always true; responses are summed and then divided by 9 (the number of items). The minimum score is 1 and the maximum score is 7. Higher scores equal greater levels of experiential avoidance or psychological inflexibility (a worse outcome).
More information on the AAQ can be found in the following two articles:
Hayes, S. C., Strosahl, K., Wilson, K. G., Bissett, R. T., Pistorello, J., Toarmino, D., et al. (2004). Measuring experiential avoidance: A preliminary test of a working model. The Psychological Record, 54(4), 553-578.
Boelen, P. A., \& Reijntjes, A. (2008). Measuring experiential avoidance: Reliability and validity of the Dutch 9-item Acceptance and Action Questionnaire (AAQ). Journal of Psychopathology and Behavioral Assessment, 30, 241-251.
Measured: 24 weeks post-quit
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a self-report measure of perceived stress; the version used is a 10-item version. Each item is rated on a 0 to 4 scale with 0=Never and 4=Very Often. The minimum score is 0 and the maximum score is 40. Higher scores on the PSS reflect higher levels of perceived stress (a worse outcome).
More information on the PSS can be found in the following article:
Leung, D. Y., Lam, T. H., \& Chan, S. S. (2010). Three versions of Perceived Stress Scale: Validation in a sample of Chinese cardiac patients who smoke. BMC Public Health, 10, 513-519
Measured: 24 weeks post-quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James M Davis, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299909
- Sponsor's protocol ID
- 2011-0087
- Other IDs
- 1K23DA022471-01A1
- Acronym
- MTS2
- Status last verified
- Jun 2019
- First submitted
- 17 Feb 2011
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be available after June 2014 from Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
Publications
Davis JM, Manley AR, Goldberg SB, Smith SS, Jorenby DE. Randomized trial comparing mindfulness training for smokers to a matched control. J Subst Abuse Treat. 2014 Sep;47(3):213-21. doi: 10.1016/j.jsat.2014.04.005. Epub 2014 May 2.
PubMed 24957302Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Two for Development of Novel Behavioral Intervention Mindfulness Training for Smokers
- ClinicalTrials.gov ID
- NCT01299909
- Acronym / sponsor ID
- MTS2 / 2011-0087
- Conditions
- Nicotine Dependence
- Keywords
- Mindfulness Training for Smokers, Smoking, Smoking cessation, Addiction, behavioral intervention, Nicotine, Tobacco, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 1 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.
Detailed description
The MTS2 Study is funded for through a five-year K23 NIH training grant (appendix) awarded to Dr. James Davis, the Principal Investigator on this protocol. The study enrollment goal is N=240 adult smokers randomized to study treatments. Based on prior recruitment numbers, it is expected that roughly 50% (120) will choose to be in an intensive intervention and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either MTS (n = 60) or ITS (n=60). MTS is a smoking cessation intervention that provides 8 mindfulness classes over a 6-week period. ITS will provide participants will access to the Freedom From Smoking Online Premium Program (at no cost) plus 8 smoking cessation classes over a 6-week period. Participants who choose to be in a non-intensive intervention (n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line. At the Orientation Meeting, participants who decide to enter the study will be allowed to choose whether they enter an intensive or the non-intensive intervention. Intensive intervention participants will attend an additional meeting called the Introductory Meeting where they are will undergo randomization into either the MTS or ITS. The Introductory Meeting will also provide instruction on the use of nicotine patches, smoking calendars and provide intervention materials. The study employs 3 study assessment visits. Study Visit 1 follows the Orientation Meeting, Study Visit 2 is 4-weeks post-quit, Study Visit 3 is 24-weeks post-quit. All participants will receive 2 weeks of free nicotine patches and $30 for attending each of the two post-quit study visits.
The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be three years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through flyers, television, newspaper and radio advertisements.
The principal hypothesis for the study is that MTS compared to ITS will show significantly higher point prevalent Carbon Monoxide confirmed smoking abstinence rates at 4 and 24 weeks post quit. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life and bio-physiological markers such as weight, breath holding and hair cortisol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training for Smokers | Active comparator | Behavioral: Mindfulness Training for SmokersMTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches. |
| Integrated Training for Smokers | Active comparator | Behavioral: Integrated Training for SmokersITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches. |
| Quitline | Other | Behavioral: QuitlineQuitline participants will consist of participants who elect not to participate in the high-intensity treatments (Mindfulness Training for Smokers; Integrated Training for Smokers. This Quitline group is a Non-Randomized, Treatment as Usual group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years or over;
- Participants must express "high" motivation to quit smoking
- Participants must express willingness to attend "all" meetings for 2 months
- Smoke 5 or more cigarettes per day
Key exclusion criteria (3 listed)
- Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
- Self report of using chewing tobacco, snuff or cigars in the last week.
- High score on Patient Health Questionnaire Depression Screening Tool for severe depression and suicidal intention.
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 |
|---|---|---|
| Integrated Training for SmokersAlso: Control Group, ITS8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program | Behavioural | Integrated Training for Smokers |
| Mindfulness Training for SmokersAlso: Study Group, MTS8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website. | Behavioural | Mindfulness Training for Smokers |
| QuitlineAlso: Non-Randomized, Treatment as UsualTelephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost. | Behavioural | Quitline |
Primary outcome
Smoking Abstinence
Time frame: 24 weeks post quit day
Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.
3 secondary outcomes
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 24 weeks post-quit
Acceptance and Action Questionnaire (AAQ)
Time frame: 24 weeks post-quit
Perceived Stress Scale (PSS)
Time frame: 24 weeks post-quit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24957302Davis JM, Manley AR, Goldberg SB, Smith SS, Jorenby DE. Randomized trial comparing mindfulness training for smokers to a matched control. J Subst Abuse Treat. 2014 Sep;47(3):213-21. doi: 10.1016/j.jsat.2014.04.005. Epub 2014 May 2.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
- Individual participant dataSharing planned: Yes. Data will be available after June 2014 from Principal Investigator James Davis, MD, who is now at Duke University (james.m.davis@duke.edu).
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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.
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?
A study testing Integrated Training for Smokers, Mindfulness Training for Smokers and Quitline in people with Nicotine Dependence, 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 4 inclusion and 3 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 27 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Abstinence (time frame: 24 weeks post quit day). 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 NCT01299909, which also lists 2 linked publications.
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 27 Jun 2019.