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SmokingNCT00297479

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

A study testing MBAT Group Therapy, Nicotine and Group Therapy in people with Smoking and Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Tobacco Use Cessation
What is being tested?
MBAT Group Therapy, Nicotine and Group Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteUnited States
Study dates
Apr 2005to Sep 2016
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 or above
  • Current smoker with a history of at least five cigarettes/day for the past year
  • Motivated to quit within the next 30 days (preparation stage)
  • Participants must provide a viable home address and a functioning home telephone number
  • Can read and write in English
  • Register "8" or more on a carbon monoxide breath test
  • Provide viable collateral contact information

Who cannot join

  • Contraindication for nicotine patch use
  • Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
  • Use of bupropion or nicotine patch replacement products other than the study patches
  • Pregnancy or lactation
  • Another household member enrolled in the study
  • Active substance dependence (exclusive of nicotine dependence)
  • Current psychiatric disorder; current use of psychotropic medication
  • Participation in a smoking cessation program or study during the past 90 days

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Group Therapy for Nicotine Dependence

The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Read the detailed description

This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures.

Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT. UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline). ST is a standard smoking cessation group program using a problem-solving/coping skills approach. MBAT is a group smoking cessation program derived from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. MBAT will not alter the basic mindfulness approach used in MBCT and MBSR, but will replace depression-related material with smoking cessation strategies from the Guideline. All participants will receive nicotine patches and self-help materials. MBAT mechanisms and effects will be assessed using "implicit" cognitive psychological measures and computer-administered questionnaires. Participants will be tracked from baseline through 4 (UC) or 8 (ST and MBAT) treatment visits and follow-up visits 1 and 23 weeks post-treatment.

The overarching goals are to evaluate MBAT's efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Primary specific aims are to:

  1. Examine the effects of MBAT on abstinence rates
  2. Examine the effects of MBAT on mindfulness/metacognitive awareness, attentional control, smoking automaticity, smoking associations in memory, negative affect, depression, stress, affect regulation expectancies, self-efficacy, withdrawal, and coping across the pre- and post-cessation period, and whether these variables mediate MBAT effects on abstinence.
Being tested
MBAT Group Therapy, Nicotine, Group Therapy, Individual Therapy
Keywords
Tobacco Cessation, Smoking Cessation
Medical subject headings
Smoking, Tobacco Use Cessation, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBAT Group TherapyBehavioural

    Also called therapy, counseling

    In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence

  • NicotineDrug

    Also called nicotine patch therapy

    6 weeks of nicotine patch therapy

  • Group TherapyBehavioural

    Also called counseling

    In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

  • Individual TherapyBehavioural

    Also called counseling

    In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

Study groups in NCT00297479
Study groupRoleWhat they receive
Mindfulness-Based Treatment Group (MBAT)ExperimentalMBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
Receives: Behavioral: MBAT Group Therapy; Drug: Nicotine
Standard Care GroupActive comparatorStandard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Receives: Drug: Nicotine; Behavioral: Group Therapy
Usual Care GroupActive comparatorUsual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
Receives: Drug: Nicotine; Behavioral: Individual Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Smoking Abstinence

    Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

    Measured: 4 weeks post quit day (one week following the end of treatment)

  2. Smoking Abstinence

    Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

    Measured: 26 weeks post quit day

  3. Smoking Abstinence

    Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

    Measured: 4 weeks post quit day (one week following the end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2006 (estimated)
  2. Study startApr 2005
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

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
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297479
Sponsor's protocol ID
2004-0988
Other IDs
R01DA018875, NCI-2012-02081
Status last verified
Jun 2020
First submitted
24 Feb 2006
Last updated
16 Jun 2020
Data monitoring committee
Yes

Publications

  • Jackson 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

  • Vidrine JI, Businelle MS, Reitzel LR, Cao Y, Cinciripini PM, Marcus MT, Li Y, Wetter DW. Coping Mediates the Association of Mindfulness with Psychological Stress, Affect, and Depression Among Smokers Preparing to Quit. Mindfulness (N Y). 2015 Jun;6(3):433-443. doi: 10.1007/s12671-014-0276-4. Epub 2014 Jan 18.

    PubMed 28191263

Questions about this trial

What is this clinical trial studying?

A study testing MBAT Group Therapy, Nicotine and Group Therapy in people with Smoking and Tobacco Use Cessation, run by M.D. Anderson Cancer Center 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 8 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 16 Jun 2020. 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 16 Jun 2020). 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?

Number of Participants With Smoking Abstinence (time frame: 4 weeks post quit day (one week following the end of treatment)). The study lists 3 primary outcomes in all. 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 NCT00297479, 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 16 Jun 2020.

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