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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
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Cognitive behavioral therapy Behavioral: Health education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in activation in reward processing regions of the brain [ Time Frame: Change from Baseline to Week 4 ]

Secondary Outcome Measures :
  1. Change in activation in cognitive control regions of the brain [ Time Frame: Change from Baseline to Week 4 ]
  2. Change in connectivity between reward and cognitive control regions of the brain [ Time Frame: Change from Baseline to Week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • smoke > 10 cigarettes per day
  • vision is normal or corrected-to-normal

Exclusion Criteria:

  • serious medical illness unsuitable for the MR scanner based on best clinical judgment
  • any neurologic or psychiatric disorder
  • diabetes
  • known heart disease
  • high blood pressure
  • currently taking psychotropic or cardiovascular medication
  • history of alcohol or other substance dependence or current abuse
  • risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
  • pregnancy

Information from the National Library of Medicine

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


Locations
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United States, Kansas
Hoglund Brain Imaging Center, University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Laura Martin, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03085602     History of Changes
Other Study ID Numbers: STUDY00001782
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No