Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07466875

Auricular Acupressure Combined With Nicotine Replacement Therapy for Nicotine Craving and Withdrawal in Psychiatric Inpatients: A Pilot Randomized Controlled Trial

Led by Chiao-Chiao Liao · Updated on 2026-04-13

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the combined use of auricular acupressure (ear seeds) and nicotine replacement therapy (NRT) among psychiatric inpatients aged 18 to 65 who are required to abstain from smoking due to a smoke-free hospital environment. The study aims to determine if auricular acupressure can reduce nicotine withdrawal symptoms, craving, and anxiety compared to standard care with NRT alone. Participants will be randomly assigned to receive either active or sham auricular acupressure alongside their NRT treatment. Participants will all receive standard NRT prescribed by their psychiatrists, including nicotine patches or gum at doses tailored to their nicotine dependence level. The experimental group will have Vaccaria seeds applied to five specific ear acupuncture points, while the control group will receive sham patches without seeds. Both groups will press the ear patches three times daily for four weeks, with weekly replacement of the patches to maintain hygiene and adhesion. During the study, participants will complete assessments measuring craving, nicotine withdrawal symptoms, and anxiety levels at baseline, day 14, and day 28. Heart rate variability will also be monitored to assess autonomic nervous system function. The research team will closely track adherence and any changes in symptoms throughout the 28-day intervention period to evaluate the potential benefits of adding auricular acupressure to standard nicotine replacement therapy.

CONDITIONS

Brief Title

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Psychiatric inpatients aged 18 to 65 years
  • Diagnosed with a mental disorder according to ICD-10-CM criteria
  • History of daily smoking within the past six months with a nicotine dependence score of 2 or higher (FTND 2)
  • Experiencing nicotine withdrawal symptoms with a baseline MNWS score of 5 or more
  • Agree to and comply with standard-of-care Nicotine Replacement Therapy provided by the hospital
  • Capable of understanding study procedures and providing written informed consent
Not Eligible

You will not qualify if you...

  • Severe skin infection, open wounds, or lesions on the outer ear
  • Severe coagulation disorders or current use of high-dose anticoagulants
  • Pregnant or breastfeeding women
  • Significant language barriers or cognitive impairment preventing assessment completion or protocol adherence
  • History of auricular therapy for smoking cessation within the past three months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 28 days

Participants receive standard Nicotine Replacement Therapy combined with either active or sham auricular acupressure for nicotine withdrawal. Auricular patches are replaced weekly, and participants press the patches multiple times daily to help manage cravings.

Weekly visits for patch replacement and assessments at baseline, Day 14, and Day 28

Trial Site Locations

Total: 1 location

1

Tsaotun Psychiatric Center, Ministry of Health and Welfare

Nantou City, Taiwan, 542

Actively Recruiting

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Research Team

C

Chiao Chiao Liao

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review.

Claire Shuiqing Zhang, Angela Weihong Yang, Anthony Lin Zhang...

https://pubmed.ncbi.nlm.nih.gov/24138333

The effectiveness and safety of auricular acupoint-related therapy for nicotine dependence: A systematic review and meta-analysis.

Qindong Mi, Xiaolong Zhao, Zhijun Zhang...

https://pubmed.ncbi.nlm.nih.gov/39931130