Tobacco dependence Smoking
Conditions
Interventions
Brief intervention + Vernonia lozenges,Brief intervention + Placebo lozenges
Active Comparator Drug,Placebo Comparator Behavioral
Vernonia group,Placebo group
Sponsors
Thai Health Professional Alliance Against Tobacco (ThaiPAT)
Medical Research Network of the Consortium of Thai Medical Schools
Eligibility
Sex/Gender
All
Age
20 Years to 100 Years
Inclusion criteria
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
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| continuous abstinence rate (CAR) 1 year subjective report & confirm with exhaled CO measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction 1 year subjective report | — |
Countries
Thailand
Contacts
Public ContactSuthat Rungruanghiranya
Thai Health Professional Alliance Against Tobacco
Outcome results
None listed