Neuroimaging Studies of Practice and Smoking

Smoking Cessation Clinical Trial

— COPE  

Official title:

Smoking Cessation and Brain Activation: How Practice Changes the Brain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03080844
• Other study ID #: STUDY00004095
• Secondary ID: RSG-16-023-01
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: March 26, 2020

Study information

• Verified date: March 2021
• 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 help determine whether practicing resisting the urge to smoke changes brain function or behavior among smokers.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Delay time to first cigarette
Participants asked to delay time until they smoke first cigarette of the day.
• Therapy
Participants receive tips on how to resist the urge to smoke and control cravings to smoke.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues	Change measured via functional magnetic resonance imaging (fMRI)	Baseline (Day 7) to End of Study (Day 22)
Secondary	Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues	Change measured via functional magnetic resonance imaging (fMRI)	Baseline (Day 7) to End of Study (Day 22)