Substance Use Disorder (SUD)
Conditions
Keywords
smoke cessation, cardiovascular diseases
Brief summary
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 .
Interventions
Participants in intervention group will receive a 12-week mobile phone-based intervention with follow-up at week 26.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous smoking abstinence | at week 26 after the quit date | biologically verified continuous smoking abstinence at week 26 after the quit date |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence smoking abstinence | 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 |
| self-reported continuous smoking abstinence | 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 |
Countries
China
Outcome results
None listed