Healthier Hearts and Brains in Treating Smoking: The HABITS Study (HABITS)

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Standard Behavioral Therapy; Behavioral: Mindfulness Based Addiction Therapy

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1	Behavioral: Standard Behavioral Therapy; Standard therapy to help participants with smoking cessation.
ACTIVE_COMPARATOR: 2	Behavioral: Mindfulness 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking Cessation	week 2 and 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Exhaled CO readings	baseline, weeks 2-4, post class follow-up, long term follow-up
Saliva Test	baseline
Functional Magnetic Resonance Imaging	baseline & follow-up
Urine Pregnancy Test	baseline & follow-up
Nicotine Replacement Therapy	Week 1
Self Reported Measures	baseline, post class follow-up & long term follow-up
Standard Cognitive Therapy	weeks 1-4
Mindfulness Based Cognitive Therapy	weeks 1-4

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Hilary Tindle, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (ESTIMATE): December 27, 2007

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Mindfulness; fMRI; Smoking cessation; Craving; Tobacco dependence
• Other Study ID Numbers: PRO08030007