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Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism

Key facts

Who runs it
Shenzhen Kangning Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
150 people, planned
Started
1 Nov 2023
Expected to end
31 Jul 2027
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • extinction training (nicotine cues)
  • extinction training (neutral cues)
  • Time-restricted smoking cessation
  • Time-restricted fasting
  • Time-restricted fasting with food supplemnet
Record updated
13 October 2023

Who can take part

Age
18 years to 60 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use benzodiazepines or received antipsychotic drugs within 2 weeks
  • Psychotic symptoms or a family history of mental disorders
  • A history of dependence or behavior (gambling, online games) addiction other than alcohol, drugs, etc
  • Epilepsy, craniocerebral injury history, coma history, brain organic or serious physical disease
  • Body mass index (BMI) > 30
  • Can not tolerate magnetic resonance examinations

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The 6 groups in the trial

  • smoking cessation combining with nicotine cue extinction trainingTreatment being tested

    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.

    Treatment: extinction training (nicotine cues) and Time-restricted smoking cessation

  • smoking cessation combining with neutral cue extinction trainingPlacebo, for comparison

    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.

    Treatment: extinction training (neutral cues) and Time-restricted smoking cessation

  • smoking cessation combining with fasting and nicotine cue extinction trainingTreatment being tested

    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.

    Treatment: extinction training (nicotine cues), Time-restricted smoking cessation, and Time-restricted fasting

  • smoking cessation combining with fasting and neutral cue extinction trainingPlacebo, for comparison

    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.

    Treatment: extinction training (neutral cues), Time-restricted smoking cessation, and Time-restricted fasting

  • smoking cessation combining with early lifting of fast and nicotine cue extinction trainingSham treatment, for comparison

    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.

    Treatment: extinction training (nicotine cues), Time-restricted smoking cessation, and Time-restricted fasting with food supplemnet

  • healthy controlNo study treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Orexin System on Nicotine Addiction Among Smokers and Its Neural Mechanism
Fit questions
Built from NCT05947162, who can take part
Record updated
13 October 2023