Auricular Stimulation for Nicotine 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
Chiao-Chiao Liao
60 participants
Mar 23, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- 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.
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Interventions
Participants will receive standard Nicotine Replacement Therapy (NRT) as prescribed by their attending psychiatrist (e.g., nicotine patches or gum). In addition, active auricular acupressure will be applied using Vaccaria seeds on five specific ear acupuncture points: Shenmen (TF4), Lung (CO14), Subcortex (AT4), Endocrine(CO18) and Sympathetic (AH6a). The intervention will last for 28 days. Participants will be instructed to press each bead for 1-2 minutes, 3 times daily (morning, noon, and evening) or whenever they feel a strong craving for a cigarette. The ear patches will be replaced every week to ensure hygiene and adhesive effectiveness.
All participants in both the experimental and control groups will receive standard-of-care Nicotine Replacement Therapy (NRT) as prescribed by their attending psychiatrist. The dosage (e.g., 21mg, 14mg, or 7mg nicotine patches; 2mg or 4mg nicotine gum) will be determined based on each patient's baseline nicotine dependence level (Fagerström Test for Nicotine Dependence) and clinical psychiatric stability. NRT administration will follow the hospital's clinical protocols for inpatient smoking cessation to manage withdrawal symptoms safely within the psychiatric ward.
Participants in the control group will receive sham auricular acupressure. To ensure blinding, placebo patches without seeds (containing inactive, non-stimulating material) that are identical in appearance to the active patches will be used. These sham patches will be applied to the same acupuncture points (Shenmen, Lung, Endocrine, Sympathetic, and Subcortex) as the experimental group. Participants will receive the same instructions to apply manual pressure 3 to 5 times daily, maintaining consistency in behavioral intervention and ensuring the integrity of the double-blind design.
Locations(1)
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NCT07466875