Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism

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:

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.

Conditions

• Tobacco Use Disorder

Interventions

BEHAVIORAL

extinction training (nicotine cues)

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

BEHAVIORAL

extinction training (neutral cues)

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

BEHAVIORAL

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.

BEHAVIORAL

Time-restricted fasting

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

BEHAVIORAL

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.

Sponsors & Collaborators

• Shenzhen Kangning Hospital

  lead OTHER

Principal Investigators

• Gengdi Huang, PhD · Shenzhen Kangning Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• China

Study Locations