BACKGROUND: Smoking is the largest preventable cause of death and disease 
worldwide but smokers often fail to quit due to nicotine withdrawal symptoms. 
Current available pharmaceutical therapies may assist with smoking cessation but 
may have side effects. Ear acupressure (EAP) and ear acupuncture have been used 
for smoking cessation, and some positive results have been reported. The aim of 
the study is to assess the efficacy and safety of EAP in assisting individuals 
to quit smoking and/or support them in the management of nicotine withdrawal 
symptoms.
METHODS: This study will be a randomised, single-blind, sham-controlled study 
conducted at RMIT University in Melbourne, Australia. Adult smokers will be 
randomly assigned to receive EAP specifically for smoking cessation or 
nonspecific EAP treatments. After a 2-week run-in, participants will be treated 
once a week for 8 weeks and followed up for 12 weeks. The primary outcome 
measures will be 7 day point-prevalence cessation rate by self-report validated 
by expired carbon monoxide and nicotine withdrawal symptoms measured by the Mood 
and Physical Symptoms Score questionnaire. Secondary outcomes will be 
self-reported usage of nicotine replacement therapies, cigarette consumption, 
body weight change and quality of life. The safety end point will be 
self-reported adverse events associated with EAP. Intention-to-treat analysis 
will be applied.
DISCUSSION: Findings from this study will determine if this EAP intervention 
alone can be an effective and safe therapy to assist with smoking cessation and 
the management of nicotine withdrawal symptoms.