Cigarette SmokingNCT01144689
Mindfulness Training for Smoking Cessation
A study testing Mindfulness Training and Smoking Cessation Therapy in people with Cigarette Smoking and Tobacco Smoking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cigarette Smoking, Tobacco Smoking, Nicotine Dependence
- What is being tested?
- Mindfulness Training and Smoking Cessation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 60
- Smoking 10 or more cigarettes per day
- Fewer than 3 months of smoking abstinence in the past year
- Motivated to stop smoking
Who cannot join
- Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
- Use of another investigational drug within 30 days
- Any serious or unstable disease within 6 months
- Meets criteria for substance dependence within the past year
- Left handed (will be excluded from fMRI only)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction
The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.
- Being tested
- Mindfulness Training, Smoking Cessation Therapy
- Keywords
- mindfulness, smoking, stress
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking, Tobacco Use Disorder, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
8 sessions of behavioral treatment for smoking cessation
Smoking Cessation TherapyBehavioural
8 sessions of behavioral treatment for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Experimental | Not described Receives: Behavioral: Mindfulness Training |
| Smoking Cessation Therapy | Active comparator | Not described Receives: Behavioral: Smoking Cessation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group differences in continuous abstinence
Measured: during treatment and 6, 12 and 18 weeks after treatment initiation
Secondary outcomes (1)
Between group differences in perceived stress
Measured: 6, 12 and 18 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startFeb 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144689
- Sponsor's protocol ID
- 0808004113
- Status last verified
- Jul 2016
- First submitted
- 14 Jun 2010
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
PubMed 21723049Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.
PubMed 23265088Kober H, Brewer JA, Height KL, Sinha R. Neural stress reactivity relates to smoking outcomes and differentiates between mindfulness and cognitive-behavioral treatments. Neuroimage. 2017 May 1;151:4-13. doi: 10.1016/j.neuroimage.2016.09.042. Epub 2016 Sep 28.
PubMed 27693614
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction
- ClinicalTrials.gov ID
- NCT01144689
- Acronym / sponsor ID
- 0808004113
- Keywords
- mindfulness, smoking, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Jun 2010 (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 assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: Mindfulness Training |
| Smoking Cessation Therapy | Active comparator | Behavioral: Smoking Cessation Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 60
- Smoking 10 or more cigarettes per day
- Fewer than 3 months of smoking abstinence in the past year
- Motivated to stop smoking
Key exclusion criteria (5 listed)
- Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment.
- Use of another investigational drug within 30 days
- Any serious or unstable disease within 6 months
- Meets criteria for substance dependence within the past year
- Left handed (will be excluded from fMRI only)
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 |
|---|---|---|
| Mindfulness Training8 sessions of behavioral treatment for smoking cessation | Behavioural | Mindfulness Training |
| Smoking Cessation Therapy8 sessions of behavioral treatment for smoking cessation | Behavioural | Smoking Cessation Therapy |
Primary outcome
Between group differences in continuous abstinence
Time frame: during treatment and 6, 12 and 18 weeks after treatment initiation
1 secondary outcome
Between group differences in perceived stress
Time frame: 6, 12 and 18 weeks after treatment initiation
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 7 Jul 2016.
- Results publication: PubMed 21723049Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
- Results publication: PubMed 23265088Elwafi HM, Witkiewitz K, Mallik S, Thornhill TA 4th, Brewer JA. Mindfulness training for smoking cessation: moderation of the relationship between craving and cigarette use. Drug Alcohol Depend. 2013 Jun 1;130(1-3):222-9. doi: 10.1016/j.drugalcdep.2012.11.015. Epub 2012 Dec 21.
- Derived from this study: PubMed 27693614Kober H, Brewer JA, Height KL, Sinha R. Neural stress reactivity relates to smoking outcomes and differentiates between mindfulness and cognitive-behavioral treatments. Neuroimage. 2017 May 1;151:4-13. doi: 10.1016/j.neuroimage.2016.09.042. Epub 2016 Sep 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Smoking Cessation Therapy in people with Cigarette Smoking and Tobacco Smoking, run by Yale University 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 5 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 7 Jul 2016. 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?
Between group differences in continuous abstinence (time frame: during treatment and 6, 12 and 18 weeks after treatment initiation). 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 NCT01144689, which also lists 3 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 7 Jul 2016.