Neuroimaging Studies of Practice and Smoking (COPE)

University of Kansas

Status: Terminated

Conditions: Smoking Cessation

Treatments: Behavioral: Therapy; Behavioral: Delay time to first cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT03080844

RSG-16-023-01 (Other Grant/Funding Number)

STUDY00004095

Details and patient eligibility

About

The purpose of this research study is to help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.

Full description

The study is comprised of two parts: a pilot to test procedures to be used in the study, followed by the study. The pilot phase of this study will enroll 30 participants. The main study will enroll 80 after the pilot phase is completed. The pilot phase includes all of the same procedures as the main study.

Enrollment: 79 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Smoke > 10 cigarettes per day for the last 6 months
• Smokes first cigarette within 60 minutes after waking
• Vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
• Willing to complete all appointments and change smoking behaviors for 2 weeks
• No quit attempts or attempts to cut back in the last 30 days
• No plans to quit in the next 30 days
• High school graduate or General Eduction Diploma (GED)

Exclusion criteria

• Serious medical illness unsuitable for the magnetic resonance imaging (MRI) scanner based on best clinical judgment
• Any neurologic or psychiatric disorder except depression, anxiety (including post-traumatic stress disorder), or attention-deficit disorder/attention-deficit hyperactivity disorder
• Currently taking anti-seizure medication
• History of concussion
• Body mass index (BMI) over 50
• Left-handedness
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

Practice

Experimental group

Description:

Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.

Treatment:

Behavioral: Therapy

Behavioral: Delay time to first cigarette

No Practice

Active Comparator group

Description:

Participants will continue with their normal smoking behavior.

Treatment:

Behavioral: Therapy