Smoking CessationNCT02298127
Auricular Acupressure for Smoking Cessation
A study testing Auricular acupressure in people with Smoking Cessation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings. 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?
- Auricular acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2014to Jun 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
- Aged 18 years and over
- Currently smoking at least one cigarette per day in the past 30 days
- Are Hong Kong residents
- Able to communicate in Cantonese
- Currently reside in Hong Kong and expect to continue to do so for the next 6 months
- Have access to a telephone
Who cannot join
- Currently undergoing other smoking cessation or similar programme
- With a known history of allergy to adhesive tapes or history of current otitis externa or other ear disease
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon
YW Mak, PhD, 852-2766-6421, hsywmak@polyu.edu.hk
YW Mak, PhD
About this study
Official title: Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study
The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings.
Read the detailed description
Uncontrolled trials indicated that auricular acupressure is an effective treatment for addictive behaviors such as smoking cessation. However, some methodological limitations can be identified among clinical trials in this area, and it is not clear whether it is more efficacious to use the commonly-used acupoints or other points that are specifically for reducing the withdrawal symptoms of nicotine. The study addresses the identified methodological shortcomings of the previous similar studies. It consists of a total of three intervention groups, which allows comparisons between the commonly-used acupoints of acupressure, acupoints specific to smoking cessation, and a sham-controlled intervention. The study does not only focus on the efficacy of smoking cessation but also assesses the mediate effect of auricular acupressure on nicotine withdrawal by questionnaire and biomarkers.
This is the first study of its kind to yield information on the acceptability and effectiveness of a safe, available auricular acupressure technique on smoking cessation in Hong Kong. The findings could provide further information for the development of future tobacco-control activities targeting smokers in a wider population who would like to use acupressure as a treatment option.
- Conditions
- Smoking Cessation
- Being tested
- Auricular acupressure
- Keywords
- smoking cessation, auricular acupressure, primary care settings, randomized controlled trial
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureOther
For each auricular acupressure weekly session, magnetic ears tacks will be will be applied by certified traditional Chinese medicine practitioners according to the allocated group assignment, for a duration of one month.
| Study group | Role | What they receive |
|---|---|---|
| Shenmen, mouth, lung & stomach | Experimental | Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the shenmen, mouth, lung and stomach. Receives: Other: Auricular acupressure |
| Subcortex,endocrine&sympathetic systems | Experimental | Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the subcortex, endocrine and sympathetic systems. Receives: Other: Auricular acupressure |
| Elbow, shoulder & knee | Sham comparator | Participants in this group will receive 4 weekly treatment sessions of sham-controlled acupressure on the elbow, shoulder and knee acupoints on the auricle that is non-specific to smoking cessation. Receives: Other: Auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence by self report
Measured: 1.25 month after the initial contact
7-day point prevalence by self report, validated by biochemical measures
Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking
Measured: 6 month
Withdrawal symptoms
Measured by two biomarkers for nicotine dependence: the gene expression level of nicotinic acetylcholine receptors (nAChRs) and dopamine level
Measured: 1.25 month after the initial contact
Secondary outcomes (2)
Feasibility outcome assessed in terms of participant recruitment, acupressure session attendance, retention, preference for using TCM for smoking cessation, perceived usefulness and confidence of quitting smoking by acupressure
Feasibility outcomes will be assessed in terms of participant recruitment, acupressure session attendance, retention, preference for using TCM for smoking cessation, perceived usefulness and confidence of quitting smoking by acupressure
Measured: 6 month
Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation
Subjective data on acceptability of auricular acupressure for smoking cessation will be collected at each visit
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Dr. Yim Wah Mak, The Hong Kong Polytechnic University
- Investigators
- YW Mak, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298127
- Sponsor's protocol ID
- AASC101114
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study
- ClinicalTrials.gov ID
- NCT02298127
- Acronym / sponsor ID
- AASC101114
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, auricular acupressure, primary care settings, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Nov 2014 (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.
The purpose of this study is to evaluate the potential efficacy of auricular acupressure to stimulate specific acupoints in enhancing smoking cessation by reducing nicotine withdrawal symptoms among attendees in primary healthcare settings.
Detailed description
Uncontrolled trials indicated that auricular acupressure is an effective treatment for addictive behaviors such as smoking cessation. However, some methodological limitations can be identified among clinical trials in this area, and it is not clear whether it is more efficacious to use the commonly-used acupoints or other points that are specifically for reducing the withdrawal symptoms of nicotine. The study addresses the identified methodological shortcomings of the previous similar studies. It consists of a total of three intervention groups, which allows comparisons between the commonly-used acupoints of acupressure, acupoints specific to smoking cessation, and a sham-controlled intervention. The study does not only focus on the efficacy of smoking cessation but also assesses the mediate effect of auricular acupressure on nicotine withdrawal by questionnaire and biomarkers.
This is the first study of its kind to yield information on the acceptability and effectiveness of a safe, available auricular acupressure technique on smoking cessation in Hong Kong. The findings could provide further information for the development of future tobacco-control activities targeting smokers in a wider population who would like to use acupressure as a treatment option.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shenmen, mouth, lung & stomach | Experimental | Other: Auricular acupressureParticipants in this group will receive 4 weekly treatment sessions of auricular acupressure via the shenmen, mouth, lung and stomach. |
| Subcortex,endocrine&sympathetic systems | Experimental | Other: Auricular acupressureParticipants in this group will receive 4 weekly treatment sessions of auricular acupressure via the subcortex, endocrine and sympathetic systems. |
| Elbow, shoulder & knee | Sham comparator | Other: Auricular acupressureParticipants in this group will receive 4 weekly treatment sessions of sham-controlled acupressure on the elbow, shoulder and knee acupoints on the auricle that is non-specific to smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years and over
- Currently smoking at least one cigarette per day in the past 30 days
- Are Hong Kong residents
- Able to communicate in Cantonese
- Currently reside in Hong Kong and expect to continue to do so for the next 6 months
Key exclusion criteria (2 listed)
- Currently undergoing other smoking cessation or similar programme
- With a known history of allergy to adhesive tapes or history of current otitis externa or other ear disease
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 |
|---|---|---|
| Auricular acupressureFor each auricular acupressure weekly session, magnetic ears tacks will be will be applied by certified traditional Chinese medicine practitioners according to the allocated group assignment, for a duration of one month. | Other | Elbow, shoulder & knee, Shenmen, mouth, lung & stomach, Subcortex,endocrine&sympathetic systems |
Primary outcome
7-day point prevalence by self report
Time frame: 1.25 month after the initial contact
7-day point prevalence by self report, validated by biochemical measures
Time frame: 6 month
Obtaining CO measurement and testing urinary cotinine for those participants who report quitting smoking
Withdrawal symptoms
Time frame: 1.25 month after the initial contact
Measured by two biomarkers for nicotine dependence: the gene expression level of nicotinic acetylcholine receptors (nAChRs) and dopamine level
2 secondary outcomes
Feasibility outcome assessed in terms of participant recruitment, acupressure session attendance, retention, preference for using TCM for smoking cessation, perceived usefulness and confidence of quitting smoking by acupressure
Time frame: 6 month
Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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.
YW Mak, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in people with Smoking Cessation, run by The Hong Kong Polytechnic University at 1 site in 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YW Mak, PhD (852-2766-6421, hsywmak@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence by self report (time frame: 1.25 month after the initial contact). The study lists 3 primary outcomes in all. 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 21 Nov 2014.