Behavioral Therapy for Reduction in Smoking Craving

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Dependence
• Intervention / Treatment: Behavioral: standard cognitive behavioral therapy; Behavioral: Mindfulness Based Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• 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: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Active Comparator: 1	Behavioral: standard cognitive behavioral therapy; Standard therapy to help participants with smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of recruitment and retention of participants	baseline - session 8 and 6 month follow-up
Participant acceptability of novel behavioral intervention (mindfulness)	baseline - session 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Smoking cessation	baseline - session 8 and 6 month follow-up
Exhaled CO readings	baseline, sessions 5 & 8
Salivary cotinine measures	baseline and sessions 5 & 8
Psychological Measures	baseline & session 8
Craving response from a smoking cue (fMRI)	Sessions 1,5, & 8
Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)	Sessions 1,5, & 8
Self Reported Measures:	baseline, sessions 5 & 8
Trait Self-Control Scale	baseline & session 8
State Ego Depletion Scale	baseline & session 8
Self-Efficacy Scale	baseline & session 8
Perceived Stress Scale	baseline & session 8
Positive and Negative Affect Scale	baseline & session 8
Difficulties in Emotional Regulation Scale	baseline & session 8
Snaith-Hamilton Hedonic Capacity Scale	baseline & session 8
Mindful Attention Awareness Scale	baseline & session 8
Kentucky Inventory of Mindfulness Scales	baseline & session 8
Mindfulness meditation practice (mindfulness participants only, time in minutes	sessions 1-8

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. doi: 10.1097/01.psy.0000077505.67574.e3.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: March 16, 2007
• First Submitted That Met QC Criteria: March 16, 2007
• First Posted (Estimate): March 20, 2007

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Mindfulness; fMRI; Smoking cessation; Craving; Tobacco dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 0606054