Overview

This trial is active, not recruiting.

Conditions smoking cessation, tobacco dependence
Treatments standard cognitive behavioral therapy, mindfulness based cognitive therapy
Sponsor University of Pittsburgh
Start date October 2006
End date June 2007
Trial size 40 participants
Trial identifier NCT00449293, 0606054

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
standard cognitive behavioral therapy
Standard therapy to help participants with smoking cessation.
(Active Comparator)
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.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Behavioral Therapy for Reduction in Smoking Craving
Principal investigator Hilary A Tindle, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by University of Pittsburgh.