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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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