Clinical trial NCT00449293: Behavioral Therapy for Reduction in Smoking Craving
Official title: Behavioral Therapy for Reduction in Smoking Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Tobacco Dependence
Keywords: Smoking cessation
Tobacco dependence
Mindfulness
fMRI
Craving
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Feasibility of recruitment and retention of participants
timeFrame: baseline - session 8 and 6 month follow-up
measure: Participant acceptability of novel behavioral intervention (mindfulness)
timeFrame: baseline - session 8
Secondary outcomes:
measure: Smoking cessation
timeFrame: baseline - session 8 and 6 month follow-up
measure: Exhaled CO readings
timeFrame: baseline, sessions 5 & 8
measure: Salivary cotinine measures
timeFrame: baseline and sessions 5 & 8
measure: Psychological Measures
timeFrame: baseline & session 8
measure: Craving response from a smoking cue (fMRI)
timeFrame: Sessions 1,5, & 8
measure: Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered)
timeFrame: Sessions 1,5, & 8
measure: Self Reported Measures:
timeFrame: baseline, sessions 5 & 8
measure: Trait Self-Control Scale
timeFrame: baseline & session 8
measure: State Ego Depletion Scale
timeFrame: baseline & session 8
measure: Self-Efficacy Scale
timeFrame: baseline & session 8
measure: Perceived Stress Scale
timeFrame: baseline & session 8
measure: Positive and Negative Affect Scale
timeFrame: baseline & session 8
measure: Difficulties in Emotional Regulation Scale
timeFrame: baseline & session 8
measure: Snaith-Hamilton Hedonic Capacity Scale
timeFrame: baseline & session 8
measure: Mindful Attention Awareness Scale
timeFrame: baseline & session 8
measure: Kentucky Inventory of Mindfulness Scales
timeFrame: baseline & session 8
measure: Mindfulness meditation practice (mindfulness participants only, time in minutes
timeFrame: sessions 1-8
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hilary A Tindle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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