Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism
NCT ID: NCT05947162
Last Updated: 2023-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2023-11-01
2027-07-31
Brief Summary
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* 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.
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Detailed Description
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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 day/20), 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 cue/neutral 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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smoking cessation combining with nicotine cue extinction training
Participants should stop smoking after 18:00 the night before the test. Combined with cue exposure therapy, nicotine addicts were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
extinction training (nicotine cues)
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
smoking cessation combining with neutral cue extinction training
Participants should stop smoking after 18:00 the night before the test, they are combined with cue exposure therapy, by repeatedly presenting neutral cue picture stimuli to nicotine addicts, and performing extinction training for 25 minutes.
extinction training (neutral cues)
extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
smoking cessation combining with fasting and nicotine cue extinction training
Participants should stop smoking and eating food after 18:00 the night before the test. Combined with cue exposure therapy, nicotine addicts are repeatedly presented with nicotine cue picture stimuli for extinction training, which lasts for 25 minutes.
extinction training (nicotine cues)
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Time-restricted fasting
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am.
smoking cessation combining with fasting and neutral cue extinction training
Participants should stop smoking and eating food after 18:00 the night before the test. Combined with cue exposure therapy, nicotine addicts were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
extinction training (neutral cues)
extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Time-restricted fasting
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am.
smoking cessation combining with early lifting of fast and nicotine cue extinction training
Participants should stop smoking and eating food after 18:00 the night before the test. After breakfast at 8:00 in the morning, they are combined with cue exposure therapy, by repeatedly presenting neutral cue picture stimuli to nicotine addicts, and performing extinction training for 25 minutes.
extinction training (nicotine cues)
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Time-restricted fasting with food supplemnet
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 8:00 am, then supplied with breakfast.
healthy control
Non-smoker healthy subjects matched with the smoking group in terms of age, gender, education level, etc. were used as the control group. Those healthy participants will finish fMRI scanning task.
No interventions assigned to this group
Interventions
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extinction training (nicotine cues)
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
extinction training (neutral cues)
extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessation
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Time-restricted fasting
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am.
Time-restricted fasting with food supplemnet
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 8:00 am, then supplied with breakfast.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Communicate normally with the researcher and cooperate with the researchers;
Exclusion Criteria
2. A history of dependence or behavior (gambling, online games) addiction other than alcohol, drugs, etc.;
3. Use benzodiazepines or received antipsychotic drugs within 2 weeks;
4. Epilepsy, craniocerebral injury history, coma history, brain organic or serious physical disease;
5. Body mass index (BMI) \> 30 ;
6. Can not tolerate magnetic resonance examinations.
18 Years
60 Years
ALL
Yes
Sponsors
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Shenzhen Kangning Hospital
OTHER
Responsible Party
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Huang Gengdi
Doctor
Principal Investigators
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Gengdi Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Kangning Hospital
Locations
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Shenzhen Kangning Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-K002-01-1
Identifier Type: -
Identifier Source: org_study_id
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