Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism
1 other identifier
interventional
150
1 country
1
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:
- Day 1: Fill in the scale, test the concentration of exhaled CO, collect 5ml of blood from the vein, and take about 60 minutes.
- Day 1-3: Test and record the amount of smoking for 3 days, about 5 minutes.
- Day 4-5: Collect fMRI data, for about 60 minutes, perform extinction training, for about 30 minutes
- 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
October 13, 2023
October 1, 2023
3.7 years
June 14, 2023
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in smoking craving on Visual Analog Scale of Cigarette Craving at week 2
Nicotine-specific Visual Analog Scale is a valid measurements of craving for a cigarette. Possible scores range from 0 (no craving) to 10 (want cigarette imediately). Change= (Week 2 score - baseline score)
baseline and week 2
change from baseline in smoking craving on Visual Analog Scale of Cigarette Craving at week 4
Nicotine-specific Visual Analog Scale is a valid measurements of craving for a cigarette. Possible scores range from 0 (no craving) to 10 (want cigarette imediately). Change= (Week 2 score - baseline score)
baseline and week 4
Change from baseline in orexin level at 24 hours after administration of extinction training.
Collect 5ml of venous blood from particicpants and use a detection kit to detect orexin level.
baseline and 24 hours after administration of extinction training.
Secondary Outcomes (1)
Fagerstrom Nicotine Dependence Test
baseline
Study Arms (6)
smoking cessation combining with nicotine cue extinction training
EXPERIMENTALParticipants 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.
smoking cessation combining with neutral cue extinction training
PLACEBO COMPARATORParticipants 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.
smoking cessation combining with fasting and nicotine cue extinction training
EXPERIMENTALParticipants 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.
smoking cessation combining with fasting and neutral cue extinction training
PLACEBO COMPARATORParticipants 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.
smoking cessation combining with early lifting of fast and nicotine cue extinction training
SHAM COMPARATORParticipants 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.
healthy control
NO INTERVENTIONNon-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.
Interventions
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Limiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- Body mass index (BMI) \> 30 ;
- Can not tolerate magnetic resonance examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gengdi Huang, PhD
Shenzhen Kangning Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 14, 2023
First Posted
July 17, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
October 13, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share