Behavioral Therapy for Reduction in Smoking Craving

NCT00449293 | Completed

• 1 other identifier: 0606054
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tobacco Dependence

Keywords

Smoking cessation; Tobacco dependence; Mindfulness; fMRI; Craving

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Behavioral: standard cognitive behavioral therapy

2

ACTIVE COMPARATOR

Behavioral: Mindfulness Based Cognitive Therapy

Interventions

standard cognitive behavioral therapy BEHAVIORAL

Standard therapy to help participants with smoking cessation.

1

Mindfulness Based Cognitive Therapy BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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. doi: 10.3122/jabfm.16.2.131.

  PMID: 12665179 BACKGROUND

• 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.

  PMID: 15358875 BACKGROUND

• 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.

  PMID: 12703651 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 12883106 BACKGROUND

• 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.

  PMID: 10609977 BACKGROUND

• 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.

  PMID: 11020090 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hilary A Tindle, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 20, 2007
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: May 1, 2008
• Last Updated: May 31, 2017

Record last verified: 2008-01

Locations

US (1)