Tobacco Use DisorderNCT05947162
Effect of Orexin System on Nicotine Addiction and Its Neural Mechanism
A study testing extinction training (nicotine cues), extinction training (neutral cues) and Time-restricted smoking cessation in people with Tobacco Use Disorder, run by Shenzhen Kangning Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- extinction training (nicotine cues), extinction training (neutral cues) and Time-restricted smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Qi Wang, Phd, +86 13688819667, 16981017@qq.com
Gengdi Huang, Phd
About this study
Official title: Effect of Orexin System on Nicotine Addiction Among Smokers and Its Neural Mechanism
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?
Read more
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.
Read the detailed description
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:
- Scale evaluation: Minnesota Tobacco Withdrawal Symptom Scale, Smoking Craving Scale, Short Smoking Craving Questionnaire, Nicotine Dependence Level Test to evaluate nicotine dependence and Smoking Intensity Index Scale, and record the subjects' smoking index (smoking Years × number of cigarettes smoked per day/20), and the smoking craving visual analog scale was used to indicate the degree of smoking craving. In addition, the Montreal Cognitive Scale, Barratt Impulsivity Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Hamilton Anxiety and Depression Scale and Pittsburgh Sleep Scale were collected for about 60 minutes.
- Behavioral extinction training: On the 4th and 5th days, combined with cue exposure therapy, nicotine addicts were repeatedly presented with nicotine cue/neutral cue picture stimulation for extinction training, which lasted for 25 minutes.
- Collect fMRI data: including resting state fMRI and task state fMRI on the 4th and 6th day, about 60 minutes.
- Detection of blood orexin level: 5ml of venous blood was collected on the 1st, 4th, and 6th day, and the plasma orexin-A level was measured by enzyme-linked immunosorbent assay.
- Time and method of follow-up: Follow up the subjects through outpatient clinics, telephone, WeChat, etc., record the relapse situation within 2 weeks after the intervention, record the number of cigarettes smoked every day, and return after 1 month for nicotine withdrawal Symptoms and smoking cravings were assessed, and DTI, resting state fMRI and task state fMRI data were collected for about 60 minutes.
- Conditions
- Tobacco Use Disorder
- Being tested
- extinction training (nicotine cues), extinction training (neutral cues), Time-restricted smoking cessation, Time-restricted fasting, Time-restricted fasting with food supplemnet
- Keywords
- nicotine, orexin, craving, withdrawal
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extinction training (nicotine cues)Behavioural
extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes.
extinction training (neutral cues)Behavioural
extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes.
Time-restricted smoking cessationBehavioural
Limiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am.
Time-restricted fastingBehavioural
Also called Dietary intervention
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 supplemnetBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| smoking cessation combining with nicotine cue extinction training | Experimental | 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. Receives: Behavioral: extinction training (nicotine cues); Behavioral: Time-restricted smoking cessation |
| smoking cessation combining with neutral cue extinction training | Placebo comparator | 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. Receives: Behavioral: extinction training (neutral cues); Behavioral: Time-restricted smoking cessation |
| smoking cessation combining with fasting and nicotine cue extinction training | Experimental | 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. Receives: Behavioral: extinction training (nicotine cues); Behavioral: Time-restricted smoking cessation; Behavioral: Time-restricted fasting |
| smoking cessation combining with fasting and neutral cue extinction training | Placebo comparator | 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. Receives: Behavioral: extinction training (neutral cues); Behavioral: Time-restricted smoking cessation; Behavioral: Time-restricted fasting |
| smoking cessation combining with early lifting of fast and nicotine cue extinction training | Sham comparator | 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. Receives: Behavioral: extinction training (nicotine cues); Behavioral: Time-restricted smoking cessation; Behavioral: Time-restricted fasting with food supplemnet |
| healthy control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Gengdi, Shenzhen Kangning Hospital
- Investigators
- Gengdi Huang, PhD, Principal investigator, Shenzhen Kangning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947162
- Sponsor's protocol ID
- 2023-K002-01-1
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orexin System on Nicotine Addiction Among Smokers and Its Neural Mechanism
- ClinicalTrials.gov ID
- NCT05947162
- Acronym / sponsor ID
- 2023-K002-01-1
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine, orexin, craving, withdrawal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Scale evaluation: Minnesota Tobacco Withdrawal Symptom Scale, Smoking Craving Scale, Short Smoking Craving Questionnaire, Nicotine Dependence Level Test to evaluate nicotine dependence and Smoking Intensity Index Scale, and record the subjects' smoking index (smoking Years × number of cigarettes smoked per day/20), and the smoking craving visual analog scale was used to indicate the degree of smoking craving. In addition, the Montreal Cognitive Scale, Barratt Impulsivity Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Hamilton Anxiety and Depression Scale and Pittsburgh Sleep Scale were collected for about 60 minutes.
- Behavioral extinction training: On the 4th and 5th days, combined with cue exposure therapy, nicotine addicts were repeatedly presented with nicotine cue/neutral cue picture stimulation for extinction training, which lasted for 25 minutes.
- Collect fMRI data: including resting state fMRI and task state fMRI on the 4th and 6th day, about 60 minutes.
- Detection of blood orexin level: 5ml of venous blood was collected on the 1st, 4th, and 6th day, and the plasma orexin-A level was measured by enzyme-linked immunosorbent assay.
- Time and method of follow-up: Follow up the subjects through outpatient clinics, telephone, WeChat, etc., record the relapse situation within 2 weeks after the intervention, record the number of cigarettes smoked every day, and return after 1 month for nicotine withdrawal Symptoms and smoking cravings were assessed, and DTI, resting state fMRI and task state fMRI data were collected for about 60 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| smoking cessation combining with nicotine cue extinction training | Experimental | Behavioral: extinction training (nicotine cues), Behavioral: Time-restricted smoking cessationParticipants 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 comparator | Behavioral: extinction training (neutral cues), Behavioral: Time-restricted smoking cessationParticipants 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 | Experimental | Behavioral: extinction training (nicotine cues), Behavioral: Time-restricted smoking cessation, Behavioral: Time-restricted fastingParticipants 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 comparator | Behavioral: extinction training (neutral cues), Behavioral: Time-restricted smoking cessation, Behavioral: Time-restricted fastingParticipants 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 comparator | Behavioral: extinction training (nicotine cues), Behavioral: Time-restricted smoking cessation, Behavioral: Time-restricted fasting with food supplemnetParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extinction training (nicotine cues)extinction training: were repeatedly presented with nicotine cue picture stimuli for extinction training, which lasted for 25 minutes. | Behavioural | smoking cessation combining with early lifting of fast and nicotine cue extinction training, smoking cessation combining with fasting and nicotine cue extinction training, smoking cessation combining with nicotine cue extinction training |
| extinction training (neutral cues)extinction training: were repeatedly presented with neutral cue picture stimuli for extinction training, which lasted for 25 minutes. | Behavioural | smoking cessation combining with fasting and neutral cue extinction training, smoking cessation combining with neutral cue extinction training |
| Time-restricted smoking cessationLimiting cigarette intake within each day to a shorter interval, thus, no cigarette from 18:00 pm to 10:00 am. | Behavioural | smoking cessation combining with early lifting of fast and nicotine cue extinction training, smoking cessation combining with fasting and neutral cue extinction training, smoking cessation combining with fasting and nicotine cue extinction training, smoking cessation combining with neutral cue extinction training, smoking cessation combining with nicotine cue extinction training |
| Time-restricted fastingAlso: Dietary interventionLimiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 10:00 am. | Behavioural | smoking cessation combining with fasting and neutral cue extinction training, smoking cessation combining with fasting and nicotine cue extinction training |
| Time-restricted fasting with food supplemnetAlso: Dietary interventionLimiting food intake within each day to a shorter interval, thus, no food from 18:00 pm to 8:00 am, then supplied with breakfast. | Behavioural | smoking cessation combining with early lifting of fast and nicotine cue extinction training |
Primary outcome
Change from baseline in smoking craving on Visual Analog Scale of Cigarette Craving at week 2
Time frame: baseline and 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)
change from baseline in smoking craving on Visual Analog Scale of Cigarette Craving at week 4
Time frame: baseline and 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)
Change from baseline in orexin level at 24 hours after administration of extinction training.
Time frame: baseline and 24 hours after administration of extinction training.
Collect 5ml of venous blood from particicpants and use a detection kit to detect orexin level.
1 secondary outcome
Fagerstrom Nicotine Dependence Test
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gengdi Huang, PhD principal investigator
Shenzhen Kangning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extinction training (nicotine cues), extinction training (neutral cues) and Time-restricted smoking cessation in people with Tobacco Use Disorder, run by Shenzhen Kangning Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gengdi Huang, PhD (+86 18600251858, gengdihuang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in smoking craving on Visual Analog Scale of Cigarette Craving at week 2 (time frame: baseline and week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.