Smoking
Conditions
Keywords
Smoking cessation, Tobacco dependence, Mindfulness, fMRI, Craving
Brief 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.
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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Smoking Cessation | week 2 and 6 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Saliva Test | baseline |
| Functional Magnetic Resonance Imaging | baseline & follow-up |
| Urine Pregnancy Test | baseline & follow-up |
| Exhaled CO readings | baseline, weeks 2-4, post class follow-up, long term follow-up |
| 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 |
| Nicotine Replacement Therapy | Week 1 |
Countries
United States
Outcome results
None listed