Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

Chiao-Chiao Liao60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Nicotine Dependence

Interventions

Auricular acupressureDEVICE

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.

Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)DRUG

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.

Sham Auricular AcupressureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Craving scale

A 100-mm Visual Analogue Scale (VAS) used to measure the participant's subjective "urge to smoke" at the moment of evaluation. The scale ranges from 1 (no craving at all) to 100 (extreme craving). Participants mark a number on the line that represents their current craving level.

Time frame: Baseline, Day 14, Day 28

Secondary Outcomes

Minnesota Nicotine Withdrawal Scale (MNWS) Total Score

The MNWS is a self-reported scale used to assess the severity of nicotine withdrawal symptoms over the past 24 hours. It consists of 9 items (e.g., urge to smoke, irritability, anxiety, difficulty concentrating). Each item is rated on a 5-point Likert scale from 0 (none) to 4 (severe). The total score ranges from 0 to 36, with higher scores indicating more severe withdrawal symptoms. A reduction of 3 points or more is pre-specified as a clinically significant improvement.

Time frame: Baseline, Day 14, and Day 28

Hamilton Anxiety Rating Scale (HAMA) Total Score

A clinician-rated scale used to evaluate the severity of anxiety symptoms. It consists of 14 items, each scored on a scale of 0 (not present) to 4 (very severe). The total score ranges from 0 to 56, where higher scores represent greater anxiety severity.

Time frame: Baseline, Day 14, and Day 28

Autonomic Nervous System Function as Measured by Heart Rate Variability

Heart Rate Variability (HRV) will be recorded using a standardized 5-minute resting protocol to evaluate the participants' autonomic nervous system (ANS) regulation. Various time-domain and frequency-domain indices will be calculated from the inter-beat interval (IBI) data. Higher variability generally reflects better adaptive capacity of the ANS in response to nicotine withdrawal stress.

Time frame: Baseline, Day28