Auricular Acupressure for Smoking Cessation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Auricular acupressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shenmen, mouth, lung & stomach<br>Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the shenmen, mouth, lung and stomach. | Other: Auricular acupressure<br>* 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.<br>|
| Experimental: Subcortex,endocrine&sympathetic systems<br>Participants in this group will receive 4 weekly treatment sessions of auricular acupressure via the subcortex, endocrine and sympathetic systems. | Other: Auricular acupressure<br>* 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.<br>|
| Sham Comparator: Elbow, shoulder & knee<br>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. | Other: Auricular acupressure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence by self report |  | 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 | 6 month | 
| Withdrawal symptoms | Measured by two biomarkers for nicotine dependence: the gene expression level of nicotinic acetylcholine receptors (nAChRs) and dopamine level | 1.25 month after the initial contact | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, auricular acupressure, primary care settings, randomized controlled trial