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

• Status: Completed
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Authority, Hong Kong
• Collaborator: Chinese University of Hong Kong
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• current smokers who smoke 10 or more cigarettes a day for at least one year

Exclusion Criteria:

• unstable angina

• severe cardiac arrhythmia

• recent acute myocardial infarction or cerebrovascular accident in preceding 3 months

• below 18 years old

• being pregnant or on breast-feeding

• unable to use gum

• with a previous history of failure to NRT

• with a history of hypersensitivity to nicotine