Brain Activity and Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT01186055|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : July 15, 2013
|Condition or disease||Intervention/treatment|
|Nicotine Dependence||Behavioral: Smoking Cessation Counseling|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Neural Mechanisms Underlying Smoking Relapse (Center for Interdisciplinary Research on Nicotine Addiction - CIRNA)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Smoking Cessation Counseling
Individuals will receive individual and group counseling for 8 weeks (6 visits) while they quit smoking.
Behavioral: Smoking Cessation Counseling
Participants shall all receive 8 weeks (6 weeks) of group or individual counseling during their quit attempt.
Other Name: Counseling
- Association between brain activity following nicotine abstinence and quit rates after 8 weeks post-target quit date [ Time Frame: 8 weeks ]The correlation between cerebral blood flow or BOLD signal changes and days to relapse will be examined using separate GLM analyses. For this analysis, each session's (abstinence, smoking) mean CBF (or BOLD signal) will be calculated for the ROIs. Mean values from each ROI will be used as predictors in a longitudinal logistic regression model of quitting success.
- Behavioral performance and BOLD signal change during neurocognitive tasks [ Time Frame: 24 hours ]To test effect of abstinence on BOLD signal during performance of various tasks, subject-level contrast maps will be entered into a voxelwise repeated-measures session (abstinent, smoking) by ANOVA. The resulting SPM maps will be transformed to unit normal distribution SPM maps and corrected for multiple comparisons (p < 0.05) using familywise error (FWE) theory and small volume correction (SVC) procedures.
- Cravings for Cigarettes [ Time Frame: 24 hours ]During scanning sessions this assessment will be administered during the Smoking Cue task before the cue exposures, once during the task, and at the end of the task.
Biospecimen Retention: Samples With DNA
- A 2ml saliva sample for DNA collection & genotyping (Oragene™).
- A 5ml saliva sample to assess nicotine metabolites (e.g. cotinine and 3-hydroxycotinine).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186055
|United States, Pennsylvania|
|3535 Market Street, Suite 4100, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Caryn Lerman, PhD||University of Pennsylvania|