Neuroimaging Studies of Smoking and Treatment

NCT ID: NCT03085602

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-02-01

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CBT Treatment

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

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type 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.

Control Group

Participants receive health education treatment. Participants will attend treatment sessions that match the CBT Treatment arm with respect to time and contact.

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

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

Control Group - Scans

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Health education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Hoglund Brain Imaging Center, University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00001782

Identifier Type: -

Identifier Source: org_study_id

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