drugset / Trial / NCT03836560

Comparing the Effectiveness of Combined NRT With Single NRT in Primary Care Clinics in Hong Kong

NCT03836560

RandomizedParallel-groupSingle-blindTreatment

Summary

The prevalence of cigarette smoking has dropped to 10% in Hong Kong (HK) in 2017, however, smoking still kills 5700 persons per year. Studies suggest that abstinence rates are higher with combined NRT than single NRT, although local data on safety and benefits of combined NRT are lacking. This is a one-year, two-arm, parallel randomized trial in 20 HK public clinics. The aim is to compare the effectiveness of combined NRT with single NRT among HK Chinese. 560 chronic smokers, who smoked ≥10 cigarettes/day for ≥ 1 year, were randomized to either intervention or usual care. Intervention group received counseling and nicotine patch \& gum. Usual care group received counselling and nicotine patch only. Primary outcome was smoking abstinence rate at 52 weeks. Secondary outcomes included smoking abstinence rate at 4, 12, \& 26 weeks. Crude odds ratio (combined NRT vs. single NRT) and p-value were reported from logistic regression without adjustment; for trend analysis, adjusted odds ratio (AOR) and p-value were reported from Generalized Estimating Equation (GEE) (controlling for time). All AORs were adjusted for age, sex, baseline CO and clusters.

Timeline

Start
2012-12-18
Primary completion
2018-02-28
Completion
2018-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 2 mg
Comparator Nicotine Unknown 7 mg

Indications

No indication recorded.