Behavioral Therapy for Reduction in Smoking Craving
Primary Purpose
Smoking Cessation, Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard cognitive behavioral therapy
Mindfulness Based Cognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking cessation, Tobacco dependence, Mindfulness, fMRI, Craving
Eligibility Criteria
Inclusion Criteria:
- Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
- Subjects must smoke at least 10 cigarettes per day
- Must be at least 18 years old
- English speaking
- Able to read, understand, and complete a written questionnaire
- Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
- Must not currently be using pharmacologic therapy to quit
- Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
- Only strongly right-handed subjects will be included
Exclusion Criteria:
- Pregnant women
- Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
- Weigh over 300 pounds
- Known problem of claustrophobia
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of recruitment and retention of participants
Participant acceptability of novel behavioral intervention (mindfulness)
Secondary Outcome Measures
Smoking cessation
Exhaled CO readings
Salivary cotinine measures
Psychological Measures
Craving response from a smoking cue (fMRI)
Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)
Self Reported Measures:
Trait Self-Control Scale
State Ego Depletion Scale
Self-Efficacy Scale
Perceived Stress Scale
Positive and Negative Affect Scale
Difficulties in Emotional Regulation Scale
Snaith-Hamilton Hedonic Capacity Scale
Mindful Attention Awareness Scale
Kentucky Inventory of Mindfulness Scales
Mindfulness meditation practice (mindfulness participants only, time in minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449293
Brief Title
Behavioral Therapy for Reduction in Smoking Craving
Official Title
Behavioral Therapy for Reduction in Smoking Craving
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects.
Detailed Description
The objective of this pilot research is to investigate the effects of two behavioral smoking cessation programs on aspects of cue-induced cigarette craving, and to further investigate the neural bases of such effects. The specific objectives of the study include 1) to investigate the effects of behavioral therapy on cue induced craving using a cognitive task and a fMRI paradigm 2) to pilot test questionnaires and study procedures, and 3) to gather preliminary estimates of the effect size of the novel behavioral therapy for smoking cessation in order to inform the design of a larger trial. A secondary goal of this research is 1) to determine the impact of two cognitive coping techniques on attentional bias to smoking related cues as measured by behavioral responses and patterns of neural activation and 2) to determine the impact of two cognitive coping techniques on cue-induced cigarette craving as measured by self-report and patterns of neural activation. Daily smokers desiring to quit smoking were randomized to one of two behavioral smoking cessation programs: (1) standard cognitive behavioral therapy or (2) mindfulness-based cognitive therapy. Participants completed questionnaires and a brief computer-based cognitive testing paradigm. Participants also underwent a fMRI scan at quit day (week 5). A randomly assigned subset of the participants (n= 18), underwent two additional scans at baseline (week 1) and end-of-therapy (week 8). The study has thus used self-report measures, cognitive testing (Stroop task), and fMRI (functional magnetic resonance imaging) assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Tobacco Dependence
Keywords
Smoking cessation, Tobacco dependence, Mindfulness, fMRI, Craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
standard cognitive behavioral therapy
Intervention Description
Standard therapy to help participants with smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Description
A novel mind body therapy that extends basic CT principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
Primary Outcome Measure Information:
Title
Feasibility of recruitment and retention of participants
Time Frame
baseline - session 8 and 6 month follow-up
Title
Participant acceptability of novel behavioral intervention (mindfulness)
Time Frame
baseline - session 8
Secondary Outcome Measure Information:
Title
Smoking cessation
Time Frame
baseline - session 8 and 6 month follow-up
Title
Exhaled CO readings
Time Frame
baseline, sessions 5 & 8
Title
Salivary cotinine measures
Time Frame
baseline and sessions 5 & 8
Title
Psychological Measures
Time Frame
baseline & session 8
Title
Craving response from a smoking cue (fMRI)
Time Frame
Sessions 1,5, & 8
Title
Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)
Time Frame
Sessions 1,5, & 8
Title
Self Reported Measures:
Time Frame
baseline, sessions 5 & 8
Title
Trait Self-Control Scale
Time Frame
baseline & session 8
Title
State Ego Depletion Scale
Time Frame
baseline & session 8
Title
Self-Efficacy Scale
Time Frame
baseline & session 8
Title
Perceived Stress Scale
Time Frame
baseline & session 8
Title
Positive and Negative Affect Scale
Time Frame
baseline & session 8
Title
Difficulties in Emotional Regulation Scale
Time Frame
baseline & session 8
Title
Snaith-Hamilton Hedonic Capacity Scale
Time Frame
baseline & session 8
Title
Mindful Attention Awareness Scale
Time Frame
baseline & session 8
Title
Kentucky Inventory of Mindfulness Scales
Time Frame
baseline & session 8
Title
Mindfulness meditation practice (mindfulness participants only, time in minutes
Time Frame
sessions 1-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Currently be cigarette smokers who desire to quit in the next 30 days (preparation phase).
Subjects must smoke at least 10 cigarettes per day
Must be at least 18 years old
English speaking
Able to read, understand, and complete a written questionnaire
Must be willing to attend 8 sessions of behavioral therapy and perform daily home practice
Must not currently be using pharmacologic therapy to quit
Must also be willing to abstain from pharmacologic therapy for the duration of the study, which is 8 weeks from the time of enrollment.
Only strongly right-handed subjects will be included
Exclusion Criteria:
Pregnant women
Have metal permanently in or on the body (aneurysm clips, permanent piercings, permanent dental work)
Weigh over 300 pounds
Known problem of claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilary A Tindle, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12665179
Citation
Astin JA, Shapiro SL, Eisenberg DM, Forys KL. Mind-body medicine: state of the science, implications for practice. J Am Board Fam Pract. 2003 Mar-Apr;16(2):131-47. doi: 10.3122/jabfm.16.2.131.
Results Reference
background
PubMed Identifier
15358875
Citation
Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: the Kentucky inventory of mindfulness skills. Assessment. 2004 Sep;11(3):191-206. doi: 10.1177/1073191104268029.
Results Reference
background
PubMed Identifier
12703651
Citation
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
Results Reference
background
PubMed Identifier
6668417
Citation
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Results Reference
background
PubMed Identifier
12883106
Citation
Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosom Med. 2003 Jul-Aug;65(4):564-70. doi: 10.1097/01.psy.0000077505.67574.e3.
Results Reference
background
PubMed Identifier
10609977
Citation
Gilbert DG, McClernon FJ, Rabinovich NE, Dibb WD, Plath LC, Hiyane S, Jensen RA, Meliska CJ, Estes SL, Gehlbach BA. EEG, physiology, and task-related mood fail to resolve across 31 days of smoking abstinence: relations to depressive traits, nicotine exposure, and dependence. Exp Clin Psychopharmacol. 1999 Nov;7(4):427-43. doi: 10.1037//1064-1297.7.4.427.
Results Reference
background
PubMed Identifier
11020090
Citation
Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.
Results Reference
background
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Behavioral Therapy for Reduction in Smoking Craving
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