Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07466875

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

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

60

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are: * Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care? * Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress. Participants will: * Receive standard nicotine replacement therapy (NRT) as prescribed by their physician. * Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points. * Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks. * Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.

CONDITIONS

Official 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 Fagerstr�f6m Test for Nicotine Dependence (FTND) score of 2 or higher
  • Experiencing nicotine withdrawal symptoms with a Minnesota Tobacco Withdrawal Scale (MNWS) baseline score of 5 or higher
  • Agree to and comply with standard Nicotine Replacement Therapy (NRT) provided by the hospital
  • Able to understand study procedures and provide 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 currently taking high-dose anticoagulants
  • Pregnant or breastfeeding women
  • Significant language barriers or cognitive impairment preventing completion of assessments or study adherence
  • History of auricular therapy for smoking cessation within the past three months

AI-Screening

AI-Powered Screening

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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

CONTACT

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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