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Neuroimaging Studies of Smoking and Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Change in activation in reward processing regions of the brain [ Time Frame: Change from Baseline to Week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03085602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Studies of Smoking and Treatment
Official Title  ICMJE Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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
  • Behavioral: Health education
    Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.
Study Arms  ICMJE
  • Experimental: CBT Treatment
    Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments.
    Intervention: Behavioral: Cognitive behavioral therapy
  • 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.
    Intervention: Behavioral: Health education
  • No Intervention: Control Group - Scans
    Participants in this new arm to the study will receive no intervention and will receive three scans.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2019)
92
Original Actual Enrollment  ICMJE
 (submitted: March 15, 2017)
41
Actual Study Completion Date  ICMJE February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03085602
Other Study ID Numbers  ICMJE STUDY00001782
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Martin, PhD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP