Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

Not Applicable

Completed

• Conditions: Cigarette Smoking; Smoking Cessation; Psychological Interventions

• Registration Number: NCT05788068
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Primary Completion: 2023-07-15
• Status Verified: 2023-08
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Biochemically Validated Continuously Abstinence	4 weeks	Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.
Brain Structural Characteristics	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	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)

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day Point Abstinence	4 weeks	Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.
Self-reported Continuous Abstinence	4 weeks	Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.

Trial Locations

Locations (1)

Yanhui Liao; 🇨🇳 Hanzhou, Zhejiang, China