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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • extinction training (nicotine cues)

    Behavioral

    extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.

  • extinction training (neutral cues)

    Behavioral

    extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.

  • Time-restricted smoking cessation

    Behavioral

    Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.

  • Time-restricted fasting

    Behavioral

    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

    Behavioral

    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.

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: smoking cessation combining with nicotine cue extinction trainingExperimental treatment 2 interventions
Group B: smoking cessation combining with neutral cue extinction trainingPlacebo comparator 2 interventions
Group C: smoking cessation combining with fasting and nicotine cue extinction trainingExperimental treatment 3 interventions
Group D: smoking cessation combining with fasting and neutral cue extinction trainingPlacebo comparator 3 interventions
Group E: smoking cessation combining with early lifting of fast and nicotine cue extinction trainingSham comparator 3 interventions
Group F: healthy controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
baseline and week 2
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)

Time frame
baseline and week 4
3

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.

Time frame
baseline and 24 hours after administration of extinction training.

Secondary outcomes

1

Fagerstrom Nicotine Dependence Test

The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Kangning Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: