Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947162
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-13
First Post:
2023-06-14
Brief Title:
Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism
Sponsor:
Shenzhen Kangning Hospital
Organization:
Shenzhen Kangning Hospital
Study Overview
Official Title:
Effect of Orexin System on Nicotine Addiction Among Smokers and Its Neural Mechanism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 weeks4 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
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 weeks4 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
Detailed Description:
Background Smoking has always been a serious public health problem in my country Nicotine is the main addictive ingredient in tobacco the mechanism of nicotine addiction is not yet clear and there is a lack of effective means to intervene in nicotine addiction In recent years the role of the orexin system in nicotine addiction has attracted great attention Multiple preclinical studies have consistently found that orexin receptor antagonists have a significant intervention effect on nicotine addiction Objective This study focuses on the role and mechanism of orexin in nicotine addiction and will reveal the neurobiological basis of orexin in nicotine addicts after withdrawal and its potential as a biomarker for predicting and preventing relapse possible Methods This study will combine neuropsychology neuroimaging and detection of plasma orexin expression levels to explore whether nicotine addiction-related behaviors including nicotine withdrawal symptoms cue-induced increased psychological craving and relapse behavior are related to plasma orexin Levels are associated and further explore the neural mechanism of its brain network Based on the detection of plasma orexin it is of great theoretical and clinical significance to verify whether it is used as a peripheral blood biomarker of nicotine addiction and to establish an objective evaluation index of nicotine addiction More specifically participants need to finish following aims
1 Scale evaluation Minnesota Tobacco Withdrawal Symptom Scale Smoking Craving Scale Short Smoking Craving Questionnaire Nicotine Dependence Level Test to evaluate nicotine dependence and Smoking Intensity Index Scale and record the subjects smoking index smoking Years number of cigarettes smoked per day20 and the smoking craving visual analog scale was used to indicate the degree of smoking craving In addition the Montreal Cognitive Scale Barratt Impulsivity Scale Self-Rating Anxiety Scale Self-Rating Depression Scale Hamilton Anxiety and Depression Scale and Pittsburgh Sleep Scale were collected for about 60 minutes
2 Behavioral extinction training On the 4th and 5th days combined with cue exposure therapy nicotine addicts were repeatedly presented with nicotine cueneutral cue picture stimulation for extinction training which lasted for 25 minutes
3 Collect fMRI data including resting state fMRI and task state fMRI on the 4th and 6th day about 60 minutes
4 Detection of blood orexin level 5ml of venous blood was collected on the 1st 4th and 6th day and the plasma orexin-A level was measured by enzyme-linked immunosorbent assay
5 Time and method of follow-up Follow up the subjects through outpatient clinics telephone WeChat etc record the relapse situation within 2 weeks after the intervention record the number of cigarettes smoked every day and return after 1 month for nicotine withdrawal Symptoms and smoking cravings were assessed and DTI resting state fMRI and task state fMRI data were collected for about 60 minutes
1 Scale evaluation Minnesota Tobacco Withdrawal Symptom Scale Smoking Craving Scale Short Smoking Craving Questionnaire Nicotine Dependence Level Test to evaluate nicotine dependence and Smoking Intensity Index Scale and record the subjects smoking index smoking Years number of cigarettes smoked per day20 and the smoking craving visual analog scale was used to indicate the degree of smoking craving In addition the Montreal Cognitive Scale Barratt Impulsivity Scale Self-Rating Anxiety Scale Self-Rating Depression Scale Hamilton Anxiety and Depression Scale and Pittsburgh Sleep Scale were collected for about 60 minutes
2 Behavioral extinction training On the 4th and 5th days combined with cue exposure therapy nicotine addicts were repeatedly presented with nicotine cueneutral cue picture stimulation for extinction training which lasted for 25 minutes
3 Collect fMRI data including resting state fMRI and task state fMRI on the 4th and 6th day about 60 minutes
4 Detection of blood orexin level 5ml of venous blood was collected on the 1st 4th and 6th day and the plasma orexin-A level was measured by enzyme-linked immunosorbent assay
5 Time and method of follow-up Follow up the subjects through outpatient clinics telephone WeChat etc record the relapse situation within 2 weeks after the intervention record the number of cigarettes smoked every day and return after 1 month for nicotine withdrawal Symptoms and smoking cravings were assessed and DTI resting state fMRI and task state fMRI data were collected for about 60 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None