An interventional study of extinction training (nicotine cues) and extinction training (neutral cues) in Tobacco Use Disorder, sponsored by Shenzhen Kangning Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Shenzhen Kangning Hospital · Not applicable, Interventional, and Treatment
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:
Participants will be asked to do as followed:
Background: Smoking has always been a serious public health problem in my country. Nicotine is the main addictive ingredient in tobacco, the mechanism of nicotine addiction is not yet clear, and there is a lack of effective means to intervene in nicotine addiction. In recent years, the role of the orexin system in nicotine addiction has attracted great attention. Multiple preclinical studies have consistently found that orexin receptor antagonists have a significant intervention effect on nicotine addiction. Objective: This study focuses on the role and mechanism of orexin in nicotine addiction, and will reveal the neurobiological basis of orexin in nicotine addicts after withdrawal, and its potential as a biomarker for predicting and preventing relapse possible. Methods: This study will combine neuropsychology, neuroimaging, and detection of plasma orexin expression levels to explore whether nicotine addiction-related behaviors, including nicotine withdrawal symptoms, cue-induced increased psychological craving, and relapse behavior are related to plasma orexin Levels are associated, and further explore the neural mechanism of its brain network. Based on the detection of plasma orexin, it is of great theoretical and clinical significance to verify whether it is used as a peripheral blood biomarker of nicotine addiction and to establish an objective evaluation index of nicotine addiction. More specifically, participants need to finish following aims:
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Shenzhen Kangning Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: extinction training (nicotine cues) · Behavioral: Time-restricted smoking cessation
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.
Behavioral: extinction training (neutral cues) · Behavioral: Time-restricted smoking cessation
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.
Behavioral: extinction training (nicotine cues) · Behavioral: Time-restricted smoking cessation · Behavioral: Time-restricted fasting
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.
Behavioral: extinction training (neutral cues) · Behavioral: Time-restricted smoking cessation · Behavioral: Time-restricted fasting
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.
Behavioral: extinction training (nicotine cues) · Behavioral: Time-restricted smoking cessation · Behavioral: Time-restricted fasting with food supplemnet
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.
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.
Also known as: Dietary intervention
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.
Also known as: Dietary intervention
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
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
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Jul 2027, 44 months later.
Of 255 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 44 months is above that.
Counting every sponsor, half of 265 studies reached it within 32 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Shenzhen Kangning Hospital