Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Ear acupressure plus nicotine replacement to ease withdrawal in psychiatric inpatients

Official title: The Efficacy of Auricular Acupressure Combined With Nicotine Replacement Therapy on Nicotine Craving, Withdrawal Symptoms and Anxiety Levels in Psychiatric Inpatients: A Pilot Randomized Controlled Trial

Run by TsaoTun Psychiatric Center, Department of Health, Taiwan · NCT07466875 · Data updated 2026-11-12

This study will test whether adding ear acupressure (ear seeds) to standard nicotine replacement therapy helps psychiatric inpatients who must stop smoking reduce withdrawal symptoms, cravings, and anxiety.

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Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorTsaoTun Psychiatric Center, Department of Health, Taiwan
Academic / other
Locations1 site (Nantou City)
StatusRecruiting
StartedMarch 23, 2026
Main results expectedJuly 31, 2027
Study endsDecember 31, 2027
Registry record updatedApril 13, 2026
Trial IDNCT07466875 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are psychiatric inpatients aged 18–65 who smoke daily (FTND ≥ 2), have notable withdrawal symptoms on admission (MNWS ≥ 5), and agree to use standard nicotine replacement therapy and provide informed consent.

Probably not a fit

Patients with open ear wounds or infections, major bleeding disorders or high‑dose anticoagulation, pregnant or breastfeeding women, or those with severe cognitive or language barriers are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will enroll adult psychiatric inpatients (ages 18–65) who are daily smokers and experiencing nicotine withdrawal after admission to a smoke-free ward. Participants will be randomly assigned to receive standard nicotine replacement therapy plus either active auricular acupressure (ear seeds) or a sham acupressure control. Outcomes will include severity of nicotine withdrawal, craving, and anxiety measured with standard scales and feasibility measures during the inpatient stay. The trial is designed to provide preliminary effectiveness and feasibility data for this low‑risk, nonpharmacologic adjunct.

Why it matters

Potential benefit: If successful, adding auricular acupressure could reduce withdrawal distress, cravings, and anxiety and make forced abstinence more tolerable for psychiatric inpatients.

How similar studies have gone: Small randomized and nonrandomized trials of auricular acupressure or ear stimulation for smoking cessation or withdrawal have reported mixed but sometimes promising results, though high‑quality evidence is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

  • Tsaotun Psychiatric Center, Ministry of Health and Welfare
    Nantou City, Taiwan
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.