Behavioral Therapy for Reduction in Smoking Craving

Smoking Cessation Clinical Trial

Official title:

Behavioral Therapy for Reduction in Smoking Craving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449293
• Other study ID #: 0606054
• Status: Completed
• Phase: N/A
• First received: March 16, 2007
• Last updated: May 26, 2017
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: January 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• standard cognitive behavioral therapy
Standard therapy to help participants with smoking cessation.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View 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. — View 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. — View 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. — View Citation

Outcome

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