- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085602
Neuroimaging Studies of Smoking and Treatment
April 12, 2019 updated by: University of Kansas Medical Center
Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- Hoglund Brain Imaging Center, University of Kansas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT Treatment
Participants receive Cognitive behavioral therapy (CBT).
Participants will receive 4 one hour CBT treatments.
|
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 Names:
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in activation in reward processing regions of the brain
Time Frame: Change from Baseline to Week 4
|
Change from Baseline to Week 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in activation in cognitive control regions of the brain
Time Frame: Change from Baseline to Week 4
|
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
|
Change from Baseline to Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura Martin, PhD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
March 15, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 21, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001782
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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