Neuroimaging Studies of Smoking and Treatment

NCT03085602 | Completed

• 1 other identifier: STUDY00001782
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Change in activation in reward processing regions of the brain

  Change from Baseline to Week 4

Secondary Outcomes (2)

• Change in activation in cognitive control regions of the brain

  Change from Baseline to Week 4

• Change in connectivity between reward and cognitive control regions of the brain

  Change from Baseline to Week 4

Study Arms (3)

CBT Treatment

EXPERIMENTAL

Participants receive Cognitive behavioral therapy (CBT). Participants will receive 4 one hour CBT treatments.

Behavioral: Cognitive behavioral therapy

Control Group

ACTIVE COMPARATOR

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

Control Group - Scans

NO INTERVENTION

Participants in this new arm to the study will receive no intervention and will receive three scans.

Interventions

Cognitive behavioral therapy BEHAVIORAL

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.

Also known as: CBT

CBT Treatment

Health education BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

Hoglund Brain Imaging Center, University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Laura Martin, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: December 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)