[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512031":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":66,"centralContacts":70,"locations":79,"responsibleParty":97,"collaborators":40,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":40,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":40,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":125,"whyStopped":40,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Shenzhen Kangning Hospital","OTHER",[8,15,21,26,30,36],{"label":9,"type":10,"description":11,"interventionNames":12},"smoking cessation combining with nicotine cue extinction training","EXPERIMENTAL","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.",[13,14],"Behavioral: extinction training (nicotine cues)","Behavioral: Time-restricted smoking cessation",{"label":16,"type":17,"description":18,"interventionNames":19},"smoking cessation combining with neutral cue extinction training","PLACEBO_COMPARATOR","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.",[20,14],"Behavioral: extinction training (neutral cues)",{"label":22,"type":10,"description":23,"interventionNames":24},"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.",[13,14,25],"Behavioral: Time-restricted fasting",{"label":27,"type":17,"description":28,"interventionNames":29},"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.",[20,14,25],{"label":31,"type":32,"description":33,"interventionNames":34},"smoking cessation combining with early lifting of fast and nicotine cue extinction training","SHAM_COMPARATOR","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.",[13,14,35],"Behavioral: Time-restricted fasting with food supplemnet",{"label":37,"type":38,"description":39,"interventionNames":40},"healthy control","NO_INTERVENTION","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.",null,[42,47,51,55,61],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":40},"BEHAVIORAL","extinction training (nicotine cues)","extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.",[31,22,9],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":40},"extinction training (neutral cues)","extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.",[27,16],{"type":43,"name":52,"description":53,"armGroupLabels":54,"otherNames":40},"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.",[31,27,22,16,9],{"type":43,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Time-restricted fasting","Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am.",[27,22],[60],"Dietary intervention",{"type":43,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"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.",[31],[60],[67],{"name":68,"affiliation":5,"role":69},"Gengdi Huang, PhD","PRINCIPAL_INVESTIGATOR",[71,75],{"name":68,"role":72,"phone":73,"phoneExt":40,"email":74},"CONTACT","+86 18600251858","gengdihuang@pku.edu.cn",{"name":76,"role":72,"phone":77,"phoneExt":40,"email":78},"Qi Wang, PhD","+86 13688819667","16981017@qq.com",[80],{"facility":5,"status":40,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Shenzhen","Guangdong","518118","China","CN",{"type":87,"coordinates":88},"Point",[89,90],114.0683,22.54554,{"lat":90,"lon":89},[93,95],{"name":94,"role":72,"phone":77,"phoneExt":40,"email":78},"Qi Wang, Phd",{"name":96,"role":69,"phone":40,"phoneExt":40,"email":40},"Gengdi Huang, Phd",{"type":69,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Huang Gengdi","Doctor","100512031","effect-of-orexin-system-on-nicotine-addiction-and-its-neural-mechanism-100512031",false,"NCT05947162","Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism","Effect of Orexin System on Nicotine Addiction Among Smokers and Its Neural Mechanism","Inclusion Criteria:\n\n1. Nicotine addicts who meet the DSM-V diagnostic criteria for substance dependence, that is, smoking ≥ 10 cigarettes per day and smoking age ≥ 2 years;\n2. Communicate normally with the researcher and cooperate with the researchers;\n\nExclusion Criteria:\n\n1. Psychotic symptoms or a family history of mental disorders;\n2. A history of dependence or behavior (gambling, online games) addiction other than alcohol, drugs, etc.;\n3. Use benzodiazepines or received antipsychotic drugs within 2 weeks;\n4. Epilepsy, craniocerebral injury history, coma history, brain organic or serious physical disease;\n5. Body mass index (BMI) \\> 30 ;\n6. Can not tolerate magnetic resonance examinations.",true,"ALL","18 Years","60 Years",{"count":112,"type":113},150,"ESTIMATED","INTERVENTIONAL",[116],"NA","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:\n\n* Whether nicotine addiction-related behaviors, including nicotine withdrawal symptoms, cue-induced increased psychological craving, and relapse behavior are related to plasma orexin levels ?\n* What is the neural mechanism of the orexin system in the fMRI brain network?\n\nParticipants will be asked to do as followed:\n\n1. Day 1: Fill in the scale, test the concentration of exhaled CO, collect 5ml of blood from the vein, and take about 60 minutes.\n2. Day 1-3: Test and record the amount of smoking for 3 days, about 5 minutes.\n3. Day 4-5: Collect fMRI data, for about 60 minutes, perform extinction training, for about 30 minutes\n4. 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.\n5. Follow-up (2 weeks\u002F4 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.",[119],"Tobacco Use Disorder",[121,122,123,124],"nicotine","orexin","craving","withdrawal","NOT_YET_RECRUITING","2023-10-12",{"date":128,"type":129},"2023-10-13","ACTUAL",{"date":131,"type":113},"2023-11-01",{"date":133,"type":113},"2027-07-31",{"name":5,"class":6},1]