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OpenTrials
Completed

NCT Number: NCT02935231

PMCAN for Smokers at Smoking Hotspots

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine replacement therapy (NRT)

Drug

1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.

Other names: NRT

Minimal Cessation Advice (MCA)

Behavioral

Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.

Other names: MCA

Health warning leaflet

Other

An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Primary outcomes

  1. Exhaled CO validated abstinence

    Time frame: 3 month

Secondary outcomes

  1. Self-reported past 7-day point prevalence abstinence

    Time frame: 3 month

  2. Nicotine Replacement Therapy use

    Time frame: 3 month

  3. Smoking cessation service use

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2016
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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