Neuroimaging Studies of Practice and Smoking

Not Applicable

Terminated

• Conditions: Smoking Cessation
• Interventions: Behavioral: Therapy; Behavioral: Delay time to first cigarette

• Registration Number: NCT03080844
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-26
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Practice	Therapy	Participants will continue with their normal smoking behavior.
Practice	Delay time to first cigarette	Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.
Practice	Therapy	Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.

Primary Outcome Measures

Name	Time	Method
Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues	Baseline (Day 7) to End of Study (Day 22)	Change measured via functional magnetic resonance imaging (fMRI)

Secondary Outcome Measures

Name	Time	Method
Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues	Baseline (Day 7) to End of Study (Day 22)	Change measured via functional magnetic resonance imaging (fMRI)

Trial Locations

Locations (1)

Hoglund Brain Imaging Center, University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States