Neuroimaging Studies of Smoking and Treatment

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation, Cognitive Control and Reward Processing: An fMRI Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085602
• Other study ID #: STUDY00001782
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• Health education
Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.

Locations

Country	Name	City	State
United States	Hoglund Brain Imaging Center, University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in activation in reward processing regions of the brain		Change from Baseline to Week 4
Secondary	Change in activation in cognitive control regions of the brain		Change from Baseline to Week 4
Secondary	Change in connectivity between reward and cognitive control regions of the brain		Change from Baseline to Week 4