Effectiveness & Efficiency of STEPwise Approach of Smoking Cessation System in Thailand

Phase 4

• Conditions: Tobacco dependence; Smoking

• Registration Number: TCTR20160526001
• Lead Sponsor: Thai Health Professional Alliance Against Tobacco (ThaiPAT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-26
• Study Completion: 2018-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 3397

Inclusion Criteria

•20 years old or more
•Smoke at least 10 cigarettes regularly per day.
•Addicted to Nicotine at a moderate level with more than 4 points in Fagerstrom Test of Nicotine Dependence (FTND).
•Desire to quit.
•Agree to receive smoking cessation service at a clinic if they are unable to quit smoking by using service in the community.
•Agree to receive therapy and medication and all the steps provided by the research programme.
•Willing to be followed up for 12 months.
•Not been treated with any therapy within the last 3 months.
•Not a chronic alcoholic (AUDIT score ≤7).

Exclusion Criteria

•Have severe Coronary Artery Disease.
•Pregnant or planning to become pregnant or breastfeeding.
•Have a history of any kind of allergy to tobacco cessation drugs.
•Use drugs for antidepression in the monoamine oxidase inhibitors (MAOIs) group.
•Have a history of liver disease or kidney disease.
•Have a history of epilepsy, schizophrenia or chronic depression.
•Have a history of cancer, except for skin cancer that is treated.
•Have dangerous hypertension (Systolic blood pressure>150mmHg or diastolic blood pressure>95 mmHg.
•Have a severe congenital disease that is unstable within the last six months.
•Have BMI> 38 or <15.
•Have a history of severe emphysema.
•Are chronic alcoholics (the AUDIT score> 7) or use other addictive substances.
•Refuse an initial interview and physical examination.
•Use an electric cigarette, Baraku and electric Baraku.
•ECG shows serious cardiac arrhythmias (malignant arrhythmia).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
continuous abstinence rate (CAR) 1 year subjective report & confirm with exhaled CO measurement

Secondary Outcome Measures

Name	Time	Method
Adverse reaction 1 year subjective report