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Neuroimaging Studies of Practice and Smoking (COPE)

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ClinicalTrials.gov Identifier: NCT03080844
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Delay time to first cigarette Behavioral: Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smoking Cessation and Brain Activation: How Practice Changes the Brain
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues [ Time Frame: Baseline (Day 7) to End of Study (Day 22) ]
    Change measured via functional magnetic resonance imaging (fMRI)


Secondary Outcome Measures :
  1. Decrease in percent (BOLD) signal change in reward network in response to smoking versus nonsmoking cues [ Time Frame: Baseline (Day 7) to End of Study (Day 22) ]
    Change measured via functional magnetic resonance imaging (fMRI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 GED

Exclusion Criteria:

  • Serious medical illness unsuitable for the MR 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080844


Contacts
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Contact: Andrew Fox, PhD 913-588-0173 mindlab@kumc.edu

Locations
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United States, Kansas
Hoglund Brain Imaging Center, University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Laura Martin, PhD University of Kansas Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03080844     History of Changes
Other Study ID Numbers: STUDY00004095
RSG-16-023-01 ( Other Grant/Funding Number: American Cancer Society )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No