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Completed

NCT Number: NCT00449293

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard cognitive behavioral therapy

Behavioral

Standard therapy to help participants with smoking cessation.

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.

Primary outcomes

  1. Feasibility of recruitment and retention of participants

    Time frame: baseline - session 8 and 6 month follow-up

  2. Participant acceptability of novel behavioral intervention (mindfulness)

    Time frame: baseline - session 8

Secondary outcomes

  1. Smoking cessation

    Time frame: baseline - session 8 and 6 month follow-up

  2. Exhaled CO readings

    Time frame: baseline, sessions 5 & 8

  3. Salivary cotinine measures

    Time frame: baseline and sessions 5 & 8

  4. Psychological Measures

    Time frame: baseline & session 8

  5. Craving response from a smoking cue (fMRI)

    Time frame: Sessions 1,5, & 8

  6. Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)

    Time frame: Sessions 1,5, & 8

  7. Self Reported Measures:

    Time frame: baseline, sessions 5 & 8

  8. Trait Self-Control Scale

    Time frame: baseline & session 8

  9. State Ego Depletion Scale

    Time frame: baseline & session 8

  10. Self-Efficacy Scale

    Time frame: baseline & session 8

  11. Perceived Stress Scale

    Time frame: baseline & session 8

  12. Positive and Negative Affect Scale

    Time frame: baseline & session 8

  13. Difficulties in Emotional Regulation Scale

    Time frame: baseline & session 8

  14. Snaith-Hamilton Hedonic Capacity Scale

    Time frame: baseline & session 8

  15. Mindful Attention Awareness Scale

    Time frame: baseline & session 8

  16. Kentucky Inventory of Mindfulness Scales

    Time frame: baseline & session 8

  17. Mindfulness meditation practice (mindfulness participants only, time in minutes

    Time frame: sessions 1-8

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Mar 20, 2007
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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