PMCAN for Smokers at Smoking Hotspots

September 24, 2019 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Nicotine Replacement Therapy (NRT)
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
Other Names:
  • NRT
Other: Health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
EXPERIMENTAL: 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.
Drug: Nicotine Replacement Therapy (NRT)
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
Other Names:
  • NRT
Other: Health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
Behavioral: Minimal Cessation Advice (MCA)
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
EXPERIMENTAL: Minimal Cessation Advice
This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet.
Other: Health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
Behavioral: Minimal Cessation Advice (MCA)
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
ACTIVE_COMPARATOR: Control
This control group receives a health warning leaflet.
Other: Health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exhaled CO validated abstinence
Time Frame: 3 month
3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-reported past 7-day point prevalence abstinence
Time Frame: 3 month
3 month
Nicotine Replacement Therapy use
Time Frame: 3 month
3 month
Smoking cessation service use
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Man Ping Wang, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

November 30, 2016

Study Completion (ACTUAL)

November 30, 2016

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMCANp_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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