Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

Smoking Cessation Clinical Trial

Official title:

Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05788068
• Other study ID #: 20220061
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Use cigarettes for no less than 1 year, and use cigarettes = 10 per day

2. Nicotine dependence (FTCD = 3)

3. Willing to make an attempt to quit smoking in the next month, and have not quit smoking in the past 3 months, and .

4. No other addictions except nicotine

5. Education level of junior high school or above

6. Age between 18 to 45 years old

7. Right-handed

8. No contraindication of MRI scanning

9. Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Patients who are receiving medication

2. Previous and current mental disorders,and/or mental disorders in line with DSM-5 diagnostic criteria in two departments and three generations.

3. Brain organic disease, brain injury history, coma history

4. Serious physical disease, endocrine disease history, abnormal blood picture, heart, liver and kidney function after examination

5. Pregnant and lactating women

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking Cessation

Intervention

Behavioral:
• Cognitive behavior therapy
Participants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team.

Locations

Country	Name	City	State
China	Yanhui Liao	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking Reduction and Participation	Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.	4 weeks
Primary	Biochemically Validated Continuously Abstinence	Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.	4 weeks
Primary	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.	4 weeks
Primary	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)	4 weeks
Secondary	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.	4 weeks
Secondary	Self-reported Continuous Abstinence	Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.	4 weeks