Auricular Acupressure for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02298127
• Other study ID #: AASC101114
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2014
• Last updated: November 20, 2014
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2014
• Source: The Hong Kong Polytechnic University
• Contact: YW Mak, PhD
• Phone: 852-2766-6421
• Email: hsywmak[@]polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence by self report		1.25 month after the initial contact	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No