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Clinical Trials/NCT02935231
NCT02935231
Completed
Not Applicable

Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial

The University of Hong Kong0 sites32 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Nicotine Replacement Therapy (NRT)
Conditions
Smoking Cessation
Sponsor
The University of Hong Kong
Enrollment
32
Primary Endpoint
Exhaled CO validated abstinence
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably "representative" or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial.

Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the "a-foot-into-the-door" method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones.

Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
November 30, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Wang Man-Ping

Assistant Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Adult smokers aged 18+ who smoke cigarettes daily.
  • Exhaled carbon monoxide (CO) level of 4ppm or above.
  • Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua)

Exclusion Criteria

  • Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant \<6 months) or breastfeeding.
  • Smokers who have psychiatric/psychological diseases or regular psychotropic medications
  • Smokers who are using SC medication, NRT, other SC services or projects.

Arms & Interventions

Nicotine Replacement Therapy

This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Intervention: Nicotine Replacement Therapy (NRT)

Nicotine Replacement Therapy

This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Intervention: Health warning leaflet

Minimal Cessation Advice & Nicotine Replacement Therapy

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Intervention: Nicotine Replacement Therapy (NRT)

Minimal Cessation Advice & Nicotine Replacement Therapy

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Intervention: Minimal Cessation Advice (MCA)

Minimal Cessation Advice & Nicotine Replacement Therapy

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.

Intervention: Health warning leaflet

Minimal Cessation Advice

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.

Intervention: Minimal Cessation Advice (MCA)

Minimal Cessation Advice

This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.

Intervention: Health warning leaflet

Control

This control group receives a health warning leaflet.

Intervention: Health warning leaflet

Outcomes

Primary Outcomes

Exhaled CO validated abstinence

Time Frame: 3 month

Secondary Outcomes

  • Self-reported past 7-day point prevalence abstinence(3 month)
  • Nicotine Replacement Therapy use(3 month)
  • Smoking cessation service use(3 month)

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