Neuroimaging Studies of Practice and Smoking (COPE)

Smoking Cessation and Brain Activation: How Practice Changes the Brain

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

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Delay time to first cigarette; Behavioral: Therapy

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Hoglund Brain Imaging Center, University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Practice; Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.	Behavioral: Delay time to first cigarette; Participants asked to delay time until they smoke first cigarette of the day.; Behavioral: Therapy; Participants receive tips on how to resist the urge to smoke and control cravings to smoke.
Active Comparator: No Practice; Participants will continue with their normal smoking behavior.	Behavioral: Therapy; Participants receive tips on how to resist the urge to smoke and control cravings to smoke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Laura Martin, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Fox AT, Catley D, Richter KP, Ellerbeck EF, Brucks MG, Papa VB, Martin LE. Functional brain activation changes associated with practice in delaying smoking among moderate to heavy smokers: study protocol and rationale of a randomized trial (COPE). Trials. 2018 Nov 12;19(1):623. doi: 10.1186/s13063-018-2984-x.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004095; RSG-16-023-01 (Other Grant/Funding Number: American Cancer Society)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No