PMCAN for Smokers at Smoking Hotspots

NCT02935231 | Completed DMC

• 1 other identifier: PMCANp_2016
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation

Keywords

minimal cessation advice; proactive; nicotine replacement therapy; smoking hotspots

Outcome Measures

Primary Outcomes (1)

• Exhaled CO validated abstinence

  3 month

Secondary Outcomes (3)

• Self-reported past 7-day point prevalence abstinence

  3 month

• Nicotine Replacement Therapy use

  3 month

• Smoking cessation service use

  3 month

Study Arms (4)

Nicotine Replacement Therapy

EXPERIMENTAL

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); Other: Health warning leaflet

Minimal Cessation Advice & Nicotine Replacement Therapy

EXPERIMENTAL

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); Behavioral: Minimal Cessation Advice (MCA); Other: Health warning leaflet

Minimal Cessation Advice

EXPERIMENTAL

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

Behavioral: Minimal Cessation Advice (MCA); Other: Health warning leaflet

Control

ACTIVE COMPARATOR

This control group receives a health warning leaflet.

Other: Health warning leaflet

Interventions

Nicotine Replacement Therapy (NRT) DRUG

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

Also known as: NRT

Minimal Cessation Advice & Nicotine Replacement Therapy; Nicotine Replacement Therapy

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.

Also known as: MCA

Minimal Cessation Advice; Minimal Cessation Advice & Nicotine Replacement Therapy

Health warning leaflet OTHER

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

Control; Minimal Cessation Advice; Minimal Cessation Advice & Nicotine Replacement Therapy; Nicotine Replacement Therapy

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Man Ping WANG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: September 1, 2016
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: September 25, 2019

Record last verified: 2019-09