Clinical Trial

Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism

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Summary
The goal of this clinical trial is to reveal the role and mechanism of orexin in nicotine addicts, compared to healthy control. The main questions it aims to answer are: * Whether nicotine addiction-related behaviors, including nicotine withdrawal symptoms, cue-induced increased psychological craving, and relapse behavior are related to plasma orexin levels ? * What is the neural mechanism of the orexin system in the fMRI brain network? Participants will be asked to do as followed: 1. Day 1: Fill in the scale, test the concentration of exhaled CO, collect 5ml of blood from the vein, and take about 60 minutes. 2. Day 1-3: Test and record the amount of smoking for 3 days, about 5 minutes. 3. Day 4-5: Collect fMRI data, for about 60 minutes, perform extinction training, for about 30 minutes 4. Day 6: Fill in the scale, test the concentration of CO in exhaled breath, collect 5ml of venous blood, test after subsidence and ignition test, and collect fMRI data, for about 60 minutes. 5. Follow-up (2 weeks/4 weeks): Complete the follow-up on smoking craving and relapse by phone within 2 weeks, about 5 minutes, and complete the scale and collect fMRI data in the 4th week, about 60 minutes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-07-14.
Trial Details
NCT Number NCT05947162
Lead Sponsor Shenzhen Kangning Hospital
Conditions Tobacco Use Disorder
Enrollment 150 participants
Start Date 2023-11-01
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2023-10-13