Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism
ConditionTobacco Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShenzhen Kangning Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Nicotine addicts who meet the DSM-V diagnostic criteria for substance dependence, that is, smoking ≥ 10 cigarettes per day and smoking age ≥ 2 years;
Communicate normally with the researcher and cooperate with the researchers;
Disqualifiers
Psychotic symptoms or a family history of mental disorders;
A history of dependence or behavior (gambling, online games) addiction other than alcohol, drugs, etc.;
Use benzodiazepines or received antipsychotic drugs within 2 weeks;
Epilepsy, craniocerebral injury history, coma history, brain organic or serious physical disease;
Trial design
Treatments tested in this trial
- extinction training (nicotine cues)
- extinction training (neutral cues)
- Time-restricted smoking cessation
- Time-restricted fasting
- Time-restricted fasting with food supplemnet
Treatment groups
150 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov