Smoking Cessation Clinical Trial
Official title:
Comparing the Effectiveness of Nicotine Patch With Gum Versus Nicotine Patch Alone in Smoking Cessation in Hong Kong Primary Care Clinics
Verified date | February 2019 |
Source | Hospital Authority, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 560 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Authority, Hong Kong | Chinese University of Hong Kong |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7-day point-prevalence abstinence rate at 52 weeks after quit date | During initial assessment, patient will set a quit date with the counsellor. At 52 weeks after the quit rate, counsellor will call the patient and confirm his quit status. The status was confirmed by self reporting abstinence rate and exhaled carbon monoxide level | at 52 weeks after the agreed quit date | |
Secondary | side effects profiles | side effects from nicotine replacement therapy | up to 1 year | |
Secondary | 7-day point-prevalence of abstinence rate at 26 weeks after quit date | During initial assessment, patient will set a quit date with the counsellor. At 26 weeks after the quit rate, counsellor will call the patient and confirm his quit status. The status was confirmed by self reporting abstinence rate and exhaled carbon monoxide level | at 26 weeks after the agreed quit date |
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