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Trial record 50 of 2035 for:    Smoking Cessation

Auricular Acupressure for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02298127
Recruitment Status : Unknown
Verified November 2014 by Dr. Yim Wah Mak, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Dr. Yim Wah Mak, The Hong Kong Polytechnic University

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Auricular acupressure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study
Study Start Date : July 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 7-day point prevalence by self report [ Time Frame: 1.25 month after the initial contact ]
  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298127


Contacts
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Contact: YW Mak, PhD 852-2766-6421 hsywmak@polyu.edu.hk
Contact: V Chiang 852-2766-6683 vico.chiang@polyu.edu.hk

Locations
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Hong Kong
School of Nursing, The Hong Kong Polytechnic University Recruiting
Hung Hom, Kowloon, Hong Kong
Contact: YW Mak, PhD    852-2766-6421    hsywmak@polyu.edu.hk   
Principal Investigator: YW Mak, PhD         
Sub-Investigator: V Chiang, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Food and Health Bureau, Hong Kong
Investigators
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Principal Investigator: YW Mak, PhD School of Nursing, The Hong Kong Polytechnic University

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Responsible Party: Dr. Yim Wah Mak, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02298127     History of Changes
Other Study ID Numbers: AASC101114
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Dr. Yim Wah Mak, The Hong Kong Polytechnic University:
smoking cessation
auricular acupressure
primary care settings
randomized controlled trial