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

NCT03836560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2019-02-11

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Nicotine patch

nicotine patch given for 8 weeks

DRUG

Nicotine gum

nicotine gum given as requested

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • Hospital Authority, Hong Kong

    lead OTHER_GOV

Principal Investigators

  • David Chao, FHKAM · Hospital Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836560 on ClinicalTrials.gov