Behavioral Therapy for Reduction in Smoking Craving - Full Text View

Purpose

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.

Condition	Intervention
Smoking Cessation Tobacco Dependence	Behavioral: standard cognitive behavioral therapy Behavioral: Mindfulness Based Cognitive Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Behavioral Therapy for Reduction in Smoking Craving

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Feasibility of recruitment and retention of participants [ Time Frame: baseline - session 8 and 6 month follow-up ] [ Designated as safety issue: No ]
Participant acceptability of novel behavioral intervention (mindfulness) [ Time Frame: baseline - session 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Smoking cessation [ Time Frame: baseline - session 8 and 6 month follow-up ] [ Designated as safety issue: No ]
Exhaled CO readings [ Time Frame: baseline, sessions 5 & 8 ] [ Designated as safety issue: No ]
Salivary cotinine measures [ Time Frame: baseline and sessions 5 & 8 ] [ Designated as safety issue: No ]
Psychological Measures [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Craving response from a smoking cue (fMRI) [ Time Frame: Sessions 1,5, & 8 ] [ Designated as safety issue: No ]
Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered) [ Time Frame: Sessions 1,5, & 8 ] [ Designated as safety issue: No ]
Self Reported Measures: [ Time Frame: baseline, sessions 5 & 8 ] [ Designated as safety issue: No ]
Trait Self-Control Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
State Ego Depletion Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Self-Efficacy Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Perceived Stress Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Positive and Negative Affect Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Difficulties in Emotional Regulation Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Snaith-Hamilton Hedonic Capacity Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Mindful Attention Awareness Scale [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Kentucky Inventory of Mindfulness Scales [ Time Frame: baseline & session 8 ] [ Designated as safety issue: No ]
Mindfulness meditation practice (mindfulness participants only, time in minutes [ Time Frame: sessions 1-8 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Behavioral: standard cognitive behavioral therapy Standard therapy to help participants with smoking cessation.
Active Comparator: 2	Behavioral: Mindfulness Based Cognitive Therapy 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449293

Locations

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

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Hilary A Tindle, MD, MPH

University of Pittsburgh

More Information

Publications:

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. Review.

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.

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.

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.

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.

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.

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.

Responsible Party:	Dr. Hilary Tindle, University of Pittsburgh Department of Internal Medicine
ClinicalTrials.gov Identifier:	NCT00449293 History of Changes
Other Study ID Numbers:	0606054
Study First Received:	March 16, 2007
Last Updated:	January 4, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Smoking cessation
Tobacco dependence
Mindfulness
fMRI
Craving

Additional relevant MeSH terms:

Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013