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CompletedNCT00581464HABITSUpdated Apr 27, 2017

Healthier Hearts and Brains in Treating Smoking: The HABITS Study

An interventional study of Standard Behavioral Therapy and Mindfulness Based Addiction Therapy in Smoking, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if eligible, enrolled and randomized to one of two four-week treatments for smoking cessation. The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate elements of widely-used tools for smoking cessation including managing craving and strong emotions, problem solving, tips on healthy eating and keeping active, and exercises based on cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a relaxation therapy) into standard therapy. Participants complete questionnaires and undergo an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of standard therapy or MBAT). During each scan, participants will complete a validated smoking-related cue paradigm and a validated affect labeling paradigm.

02

Conditions studied

  • Smoking

Keywords

  • Smoking cessation
  • Tobacco dependence
  • Mindfulness
  • fMRI
  • Craving
03

In context

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants will be considered eligible for enrollment if they are between 18-65 years old, smoke at least ½ pack cigarettes per day, desire to quit smoking (self-reported 75+ out of a possible 100), and have no contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).

Exclusion criteria

Exclusion Criteria:

  • Participants will not be considered eligible for enrollment if they are not between 18-65 years old, smoke less than ½ pack cigarettes per day, do not desire to quit smoking (self-reported -75 out of a possible 100), or have contraindications for varenicline medication therapy or fMRI scanning (such as body weight over 250 lbs, intravascular metal devices including stents, or claustrophobia).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Active comparator
    1

    Behavioral: Standard Behavioral Therapy

  • Active comparator
    2

    Behavioral: Mindfulness Based Addiction Therapy

Interventions

  • BehavioralStandard Behavioral Therapy

    Standard therapy to help participants with smoking cessation.

  • BehavioralMindfulness Based Addiction Therapy

    A novel mind body therapy that extends basic behavioral therapy principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.

06

What researchers measure

Primary outcomes

  1. Smoking Cessation

    Time frame: week 2 and 6 month follow-up

Secondary outcomes

  1. Exhaled CO readings

    Time frame: baseline, weeks 2-4, post class follow-up, long term follow-up

  2. Saliva Test

    Time frame: baseline

  3. Functional Magnetic Resonance Imaging

    Time frame: baseline & follow-up

  4. Urine Pregnancy Test

    Time frame: baseline & follow-up

  5. Nicotine Replacement Therapy

    Time frame: Week 1

  6. Self Reported Measures

    Time frame: baseline, post class follow-up & long term follow-up

  7. Standard Cognitive Therapy

    Time frame: weeks 1-4

  8. Mindfulness Based Cognitive Therapy

    Time frame: weeks 1-4

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00581464
Lead sponsor
University of Pittsburgh
Responsible party
Sponsor
First posted
Dec 27, 2007
Start date
Nov 2009
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Apr 27, 2017

Study contacts

Hilary Tindle, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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