Neuroimaging Studies of Smoking and Treatment
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|ClinicalTrials.gov Identifier: NCT03085602|
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Cognitive behavioral therapy Behavioral: Health education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||February 1, 2019|
Experimental: CBT Treatment
Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments.
Behavioral: Cognitive behavioral therapy
Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.
Other Name: CBT
Active Comparator: Control Group
Participants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact.
Behavioral: Health education
Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.
No Intervention: Control Group - Scans
Participants in this new arm to the study will receive no intervention and will receive three scans.
- Change in activation in reward processing regions of the brain [ Time Frame: Change from Baseline to Week 4 ]
- Change in activation in cognitive control regions of the brain [ Time Frame: Change from Baseline to Week 4 ]
- Change in connectivity between reward and cognitive control regions of the brain [ Time Frame: Change from Baseline to Week 4 ]
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): NCT03085602
|United States, Kansas|
|Hoglund Brain Imaging Center, University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Laura Martin, PhD||University of Kansas Medical Center|