Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Nicotine Dependence, Nicotine Withdrawal, Tobacco Use Disorder, Anxiety, Mental Disorders

In brief

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.

Key facts

Study ID

NCT07466875

Run by

Chiao-Chiao Liao

People needed

60

Starts

2026-03-23

Expected to finish

2027-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (Fagerström Test for Nicotine Dependence [FTND] score ≥ 2).
• Experiencing nicotine withdrawal symptoms due to mandatory smoking cessation upon admission (Minnesota Tobacco Withdrawal Scale [MNWS] baseline score ≥ 5).
• Agree to and comply with the standard-of-care Nicotine Replacement Therapy (NRT) provided by the hospital.
• Capable of understanding the study procedures and providing written informed consent

You may not qualify if…

• Presence of severe skin infection, open wounds, or lesions on the auricle (outer ear).
• Severe coagulation disorders or currently taking high-dose anticoagulants (due to potential risk of bleeding or irritation).
• Pregnant or breastfeeding women.
• Significant language barriers or cognitive impairment that prevents completion of assessment scales or adherence to study protocols.
• History of receiving auricular therapy for smoking cessation within the past three months.

Where it is running

• Tsaotun Psychiatric Center, Ministry of Health and Welfare — Nantou City, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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