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

NCT03836560 | Completed

• 1 other identifier: HA_SCCP_NRT
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

nicotine replacement therapy; smoking cessation; quit rates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• side effects profiles

  up to 1 year

• 7-day point-prevalence of abstinence rate at 26 weeks after quit date

  at 26 weeks after the agreed quit date

Study Arms (2)

Usual group

ACTIVE COMPARATOR

Usual group with nicotine patch only: Usual care involved counseling and 8 weeks of single NRT of nicotine patch. For those smoking 20 or more cigarettes per day before quitting, the NRT patch regimen was 4 weeks of 21mg patches, then 2 weeks of 14mg patches, followed by 2 weeks of 7mg patches. For those smoking 10 to 19 cigarettes per day before quitting, the NRT patch regimen was 4 weeks of 14mg patches, followed by 4 weeks of 7mg patches.

Drug: Nicotine patch

Intervention group

ACTIVE COMPARATOR

Nicotine patch and nicotine gum: Intervention consisted of counseling and 8 weeks of combined NRT of nicotine patch and gum. For those smoking 20 or more cigarettes per day before quitting, the NRT patch regimen was 4 weeks of 21mg patches, then 2 weeks of 14mg patches, followed by 2 weeks of 7mg patches. For those smoking 10 to 19 cigarettes per day before quitting, the NRT patch regimen was 4 weeks of 14mg patches, followed by 4 weeks of 7mg patches. 2mg nicotine gum was used once every 1 to 2 hours when required.

Drug: Nicotine patch; Drug: Nicotine gum

Interventions

Nicotine patch DRUG

nicotine patch given for 8 weeks

Intervention group; Usual group

Nicotine gum DRUG

nicotine gum given as requested

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Related Publications (2)

• Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

  PMID: 37335995 DERIVED

• Leung MKW, Bai D, Yip BHK, Fong MY, Lai PMH, Lai P, Lai ISY, Lam ZHW, Leung ATF, To DKY, Wong MT, Wong TK, Chao DVK. Combined nicotine patch with gum versus nicotine patch alone in smoking cessation in Hong Kong primary care clinics: a randomised controlled trial. BMC Public Health. 2019 Oct 16;19(1):1302. doi: 10.1186/s12889-019-7634-z.

  PMID: 31619205 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Chao, FHKAM

  Hospital Authority

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor did not know which arm was interventional/control during the data analysis process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Family Medicine

Model Details: One year, 2 arm, parallel, randomised controlled trial

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 11, 2019
• Study Start: December 18, 2012
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02