Auricular Acupressure for Smoking Cessation

November 20, 2014 updated by: Dr. Yim Wah Mak, The Hong Kong Polytechnic University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Kowloon
      • Hung Hom, Kowloon, Hong Kong
        • Recruiting
        • School of Nursing, The Hong Kong Polytechnic University
        • Contact:
        • Principal Investigator:
          • YW Mak, PhD
        • Sub-Investigator:
          • V Chiang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence by self report
Time Frame: 1.25 month after the initial contact
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
6 month
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
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
Time Frame: 6 month
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
Time Frame: 1 month
Subjective data on acceptability of auricular acupressure for smoking cessation will be collected at each visit
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Food and Health Bureau, Hong Kong

Investigators

  • Principal Investigator: YW Mak, PhD, School of Nursing, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 16, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AASC101114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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