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Completed

NCT Number: NCT05788068

Efficacy and Neuroimaging Mechanisms of Smoking Cessation in China

This proposed project is to assess the efficacy of CBT-based digital smoking cessation interventions in China, as well as explore its neuroimaging mechanisms.

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Key information

Conditions

Cigarette Smoking Behavior Health Behavior Psychological Interventions Smoking Smoking Cessation Tobacco Smoking Tobacco Use

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yanhui Liao

Hanzhou, Zhejiang, 360000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Right-handed
  • No contraindication of MRI scanning
  • Willing to provide informed consent to participate in the study.

Exclusion criteria

  • 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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Participants will receive CBT intervention for smoking cessation via "wechat"-based mini-program developed by a professional team.

Primary outcomes

  1. Biochemically Validated Continuously Abstinence

    Time frame: 4 weeks

    Biochemical validation of 4-week continuous smoking abstinence by urine cotinine test.

  2. 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.

  3. 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)

Secondary outcomes

  1. Self-reported 7-day Point Abstinence

    Time frame: 4 weeks

    Self-reported 7-day point-prevalence abstinence at week 1, 4, 8, 12, 16, 20 and 26 after quit date.

  2. Self-reported Continuous Abstinence

    Time frame: 4 weeks

    Self-reported continuous smoking abstinence rate at weeks 4, 8, 12, 16, 20, and 26 after the quit date.

Other outcomes

  1. Smoking Reduction and Participation

    Time frame: 4 weeks

    Reductions in number of cigarettes smoked per day and rates of participation in and completion of smoking-cessation programs.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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