Clinical trial NCT02935231: PMCAN for Smokers at Smoking Hotspots
Official title: Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: minimal cessation advice
proactive
nicotine replacement therapy
smoking hotspots
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Exhaled CO validated abstinence
timeFrame: 3 month
Secondary outcomes:
measure: Self-reported past 7-day point prevalence abstinence
timeFrame: 3 month
measure: Nicotine Replacement Therapy use
timeFrame: 3 month
measure: Smoking cessation service use
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Man Ping WANG
role: PRINCIPAL_INVESTIGATOR
References: