Cigarette SmokingNCT05788068
Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
A study testing Cognitive behavior therapy in people with Cigarette Smoking and Psychological Interventions, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cigarette Smoking, Psychological Interventions, Smoking Cessation
- What is being tested?
- Cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day
- Nicotine dependence (FTCD ≥ 3)
- Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .
- No other addictions except nicotine
- Education level of junior high school or above
- Age between 18 to 45 years old
Show all 9Show fewer
- Right-handed
- No contraindication of MRI scanning
- Willing to provide informed consent to participate in the study.
Who cannot join
- Patients who are receiving medication
- Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.
- Brain organic disease, brain injury history, coma history
- Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.
- Being tested
- Cognitive behavior therapy
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Participants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive CBT-based digital smoking cessation intervention. The intervention is a set of smoking cessation methods based on the theoretical study of cognitive behavioral therapy for smoking cessation, and its effectiveness has been confirmed through our large sample of randomized controlled studies. This study plans to intervene smokers for 4 weeks after the start of smoking cessation. Receives: Behavioral: Cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Validated Continuously Abstinence
Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.
Measured: 4 weeks
Brain Structural Characteristics
Differences of brain structure between successful and unsuccessful smokers after intervention, which will be measured by white matter volume, gray matter volume, cortical thickness, and surface area.
Measured: 4 weeks
Brain Functional activity
Differences of whole brain function activity between successful and unsuccessful smokers after intervention, which will be measured by ReHo, ALFF, fALFF, and functional connectivity (FC)
Measured: 4 weeks
Secondary outcomes (2)
Self-reported 7-day Point Abstinence
Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.
Measured: 4 weeks
Self-reported Continuous Abstinence
Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Mar 2023
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788068
- Sponsor's protocol ID
- 20220061
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng H, Sun Y, Chen H, Zhu R, Gao Y, Xie A, Liao Y. Altered controllability of functional brain networks among electronic cigarettes users with nicotine dependence. Nicotine Tob Res. 2026 Jun 24:ntag134. doi: 10.1093/ntr/ntag134. Online ahead of print.
PubMed 42340991
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China
- ClinicalTrials.gov ID
- NCT05788068
- Acronym / sponsor ID
- 20220061
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 28 Mar 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.
This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Cognitive behavior therapyParticipants in the intervention group will receive CBT-based digital smoking cessation intervention. The intervention is a set of smoking cessation methods based on the theoretical study of cognitive behavioral therapy for smoking cessation, and its effectiveness has been confirmed through our large sample of randomized controlled studies. This study plans to intervene smokers for 4 weeks after the start of smoking cessation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Use cigarettes for no less than 1 year, and use cigarettes ≥ 10 per day
- Nicotine dependence (FTCD ≥ 3)
- Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .
- No other addictions except nicotine
- Education level of junior high school or above
Key exclusion criteria (5 listed)
- Patients who are receiving medication
- Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.
- Brain organic disease, brain injury history, coma history
- Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination
- Pregnant and lactating women
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 |
|---|---|---|
| Cognitive behavior therapyParticipants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team. | Behavioural | Intervention Group |
Primary outcome
Biochemically Validated Continuously Abstinence
Time frame: 4 weeks
Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.
Brain Structural Characteristics
Time frame: 4 weeks
Differences of brain structure between successful and unsuccessful smokers after intervention, which will be measured by white matter volume, gray matter volume, cortical thickness, and surface area.
Brain Functional activity
Time frame: 4 weeks
Differences of whole brain function activity between successful and unsuccessful smokers after intervention, which will be measured by ReHo, ALFF, fALFF, and functional connectivity (FC)
2 secondary outcomes
Self-reported 7-day Point Abstinence
Time frame: 4 weeks
Self-reported Continuous Abstinence
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 42340991Zheng H, Sun Y, Chen H, Zhu R, Gao Y, Xie A, Liao Y. Altered controllability of functional brain networks among electronic cigarettes users with nicotine dependence. Nicotine Tob Res. 2026 Jun 24:ntag134. doi: 10.1093/ntr/ntag134. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavior therapy in people with Cigarette Smoking and Psychological Interventions, run by Sir Run Run Shaw 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 24 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Validated Continuously Abstinence (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT05788068, which also lists 1 linked publication.
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 24 Aug 2023.