Ear acupressure plus nicotine replacement to ease withdrawal in psychiatric inpatients
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | TsaoTun Psychiatric Center, Department of Health, Taiwan Academic / other |
| Locations | 1 site (Nantou City) |
| Trial ID | NCT07466875 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nantou City
- Tsaotun Psychiatric Center, Ministry of Health and Welfare — Nantou City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chiao Chiao Liao
- Email: l23ful6@gmail.com
- Phone: +886 963674763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.