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Behavioral Therapy for Reduction in Smoking Craving

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00449293
First received: March 16, 2007
Last updated: January 4, 2008
Last verified: January 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 25, 2014