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Clinical Trials/NCT02298127
NCT02298127
Unknown
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country90 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
The Hong Kong Polytechnic University
Enrollment
90
Locations
1
Primary Endpoint
Withdrawal symptoms
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
June 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Yim Wah Mak

Assistant Professor

The Hong Kong Polytechnic University

Eligibility 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation(1 month)
  • 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(6 month)

Study Sites (1)

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