NCT07466875 Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients
| NCT ID | NCT07466875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiao-Chiao Liao |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03-23 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07466875 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07466875 currently recruiting?
Yes, NCT07466875 is actively recruiting participants. Contact the research team at l23ful6@gmail.com for enrollment information.
Where is the NCT07466875 trial being conducted?
This trial is being conducted at Nantou City, Taiwan.
Who is sponsoring the NCT07466875 clinical trial?
NCT07466875 is sponsored by Chiao-Chiao Liao. The trial plans to enroll 60 participants.