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Completed

NCT Number: NCT06747182

Mobile Phone-based Smoking Cessation Program

In this online, randomized controlled trial (RCT), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. Participants will receive a 12-week intervention with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 2000 smokers with willingness to make a quit attempt within a month from October 2022 to April 2023 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in November 2023. The trial results will be available by the end of 2023 .

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Key information

Conditions

Substance Use Disorder (SUD) Behavior Cardiovascular Diseases Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Hangzhou, Zhejiang, 310029, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • In this RCT, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with CVDs diagnosis or risk.

Exclusion criteria

  • patients unwilling to quit smoking

Treatment and study plan

mobile phone-based intervention

Other

Participants in intervention group will receive a 12-week mobile phone-based intervention with follow-up at week 26.

Primary outcomes

  1. Continuous smoking abstinence

    Time frame: at week 26 after the quit date

    biologically verified continuous smoking abstinence at week 26 after the quit date

Secondary outcomes

  1. 7-day point prevalence smoking abstinence

    Time frame: week 1, 2, 3, 4, 8, 12, 16, 20 and 26

    seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26

  2. self-reported continuous smoking abstinence

    Time frame: week 4, 8, 12, 16, 20 and 26 after the quit date

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

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Mobile Phone-based Smoking Cessation Program for Individuals With Cardiovascular Risk or Disease in China

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2024
Registry last updated
Jun 13, 2025

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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