Smoking CessationNCT02935231
PMCAN for Smokers at Smoking Hotspots
A study testing Nicotine Replacement Therapy (NRT), Minimal Cessation Advice (MCA) and Health warning leaflet in people with Smoking Cessation, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Replacement Therapy (NRT), Minimal Cessation Advice (MCA) and Health warning leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Replacement Therapy (NRT), Minimal Cessation Advice (MCA), Health warning leaflet
- Keywords
- minimal cessation advice, proactive, nicotine replacement therapy, smoking hotspots
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT)Drug
Also called NRT
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
Minimal Cessation Advice (MCA)Behavioural
Also called 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.
Health warning leafletOther
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Minimal Cessation Advice (MCA); Other: Health warning leaflet |
| Control | Active comparator | This control group receives a health warning leaflet. Receives: Other: Health warning leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled CO validated abstinence
Measured: 3 month
Secondary outcomes (3)
Self-reported past 7-day point prevalence abstinence
Measured: 3 month
Nicotine Replacement Therapy use
Measured: 3 month
Smoking cessation service use
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start1 Sep 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping WANG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935231
- Sponsor's protocol ID
- PMCANp_2016
- Status last verified
- Sep 2019
- First submitted
- 12 Oct 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02935231
- Acronym / sponsor ID
- PMCANp_2016
- Conditions
- Smoking Cessation
- Keywords
- minimal cessation advice, proactive, nicotine replacement therapy, smoking hotspots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy | Experimental | Drug: Nicotine Replacement Therapy (NRT), Other: Health warning leafletThis 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. |
| Minimal Cessation Advice & Nicotine Replacement Therapy | Experimental | Drug: Nicotine Replacement Therapy (NRT), Behavioral: Minimal Cessation Advice (MCA), Other: Health warning leafletThis 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. |
| Minimal Cessation Advice | Experimental | Behavioral: Minimal Cessation Advice (MCA), Other: Health warning leafletThis experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet. |
| Control | Active comparator | Other: Health warning leafletThis control group receives a health warning leaflet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT)Also: NRT1-week free NRT (gum/patch) plus a card containing instruction and potential side effects. | Drug | Minimal Cessation Advice & Nicotine Replacement Therapy, Nicotine Replacement Therapy |
| Minimal Cessation Advice (MCA)Also: MCABrief 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. | Behavioural | Minimal Cessation Advice, Minimal Cessation Advice & Nicotine Replacement Therapy |
| Health warning leafletAn A4 double-side color leaflet containing shocking pictures of diseases associated with smoking. | Other | Control, Minimal Cessation Advice, Minimal Cessation Advice & Nicotine Replacement Therapy, Nicotine Replacement Therapy |
Primary outcome
Exhaled CO validated abstinence
Time frame: 3 month
3 secondary outcomes
Self-reported past 7-day point prevalence abstinence
Time frame: 3 month
Nicotine Replacement Therapy use
Time frame: 3 month
Smoking cessation service use
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Ping WANG principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy (NRT), Minimal Cessation Advice (MCA) and Health warning leaflet in people with Smoking Cessation, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled CO validated abstinence (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.