Smoking Cessation Clinical Trial
Official title:
Behavioral Therapy for Reduction in Smoking Craving
Verified date | January 2008 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2008 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of recruitment and retention of participants | baseline - session 8 and 6 month follow-up | ||
Primary | Participant acceptability of novel behavioral intervention (mindfulness) | baseline - session 8 | ||
Secondary | Smoking cessation | baseline - session 8 and 6 month follow-up | ||
Secondary | Exhaled CO readings | baseline, sessions 5 & 8 | ||
Secondary | Salivary cotinine measures | baseline and sessions 5 & 8 | ||
Secondary | Psychological Measures | baseline & session 8 | ||
Secondary | Craving response from a smoking cue (fMRI) | Sessions 1,5, & 8 | ||
Secondary | Reaction times on Smoking Stroop tasks (behavioral and fMRI-administered) | Sessions 1,5, & 8 | ||
Secondary | Self Reported Measures: | baseline, sessions 5 & 8 | ||
Secondary | Trait Self-Control Scale | baseline & session 8 | ||
Secondary | State Ego Depletion Scale | baseline & session 8 | ||
Secondary | Self-Efficacy Scale | baseline & session 8 | ||
Secondary | Perceived Stress Scale | baseline & session 8 | ||
Secondary | Positive and Negative Affect Scale | baseline & session 8 | ||
Secondary | Difficulties in Emotional Regulation Scale | baseline & session 8 | ||
Secondary | Snaith-Hamilton Hedonic Capacity Scale | baseline & session 8 | ||
Secondary | Mindful Attention Awareness Scale | baseline & session 8 | ||
Secondary | Kentucky Inventory of Mindfulness Scales | baseline & session 8 | ||
Secondary | Mindfulness meditation practice (mindfulness participants only, time in minutes | sessions 1-8 |
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