Clinical trial NCT02298127: Auricular Acupressure for Smoking Cessation
Official title: Acceptability and Potential Efficacy of a Randomised, Double-blinded, Sham-controlled Trial of Auricular Acupressure for Smoking Cessation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
auricular acupressure
primary care settings
randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2014-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 7-day point prevalence by self report
timeFrame: 1.25 month after the initial contact
measure: 7-day point prevalence by self report, validated by biochemical measures
timeFrame: 6 month
measure: Withdrawal symptoms
timeFrame: 1.25 month after the initial contact
Secondary outcomes:
measure: 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
timeFrame: 6 month
measure: Acceptability: Subjective data on acceptability of auricular acupressure for smoking cessation
timeFrame: 1 month
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: YW Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References: