PMCAN for Smokers at Smoking Hotspots

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935231
• Other study ID #: PMCANp_2016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine Replacement Therapy (NRT)
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled CO validated abstinence		3 month
Secondary	Self-reported past 7-day point prevalence abstinence		3 month
Secondary	Nicotine Replacement Therapy use		3 month
Secondary	Smoking cessation service use		3 month