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Behavioral Therapy for Reduction in Smoking Craving

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449293
First Posted: March 20, 2007
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Therapy for Reduction in Smoking Craving

Resource links provided by NLM:


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 ]
  • Participant acceptability of novel behavioral intervention (mindfulness) [ Time Frame: baseline - session 8 ]

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

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: May 2008
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00449293     History of Changes
Other Study ID Numbers: 0606054
First Submitted: March 16, 2007
First Posted: March 20, 2007
Last Update Posted: May 31, 2017
Last Verified: January 2008

Keywords provided by University of Pittsburgh:
Smoking cessation
Tobacco dependence
Mindfulness
fMRI
Craving

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders