Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients (NCT07466875) | Clinical Trial Compass
RecruitingNot Applicable
Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients
Taiwan60 participantsStarted 2026-03-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.