Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients
Recruiting · NCT07466875 · Interventional (participants receive a specific treatment) · Lead sponsor: Chiao-Chiao Liao
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed.
- Tsaotun Psychiatric Center, Ministry of Health and Welfare - Nantou City, Taiwan