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NCT Number: NCT07466875

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

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.

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Key information

Conditions

Nicotine Dependence Anxiety Anxiety Disorders Chemically-Induced Disorders Mental Disorders Nicotine Withdrawal Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsaotun Psychiatric Center, Ministry of Health and Welfare

Nantou City, 542, Taiwan

Location status: Recruiting

Location contact

Tsaotun Psychiatric Center Ministry of Health and Welfare

CONTACT

[email protected]

+886-4-9255-0800#2091

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular acupressure

Device

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.

Other names: auricular acupuncture, ear seed

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 Acupressure

Device

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.

Primary outcomes

  1. Craving scale

    Time frame: Baseline, Day 14, Day 28

    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.

Secondary outcomes

  1. Minnesota Nicotine Withdrawal Scale (MNWS) Total Score

    Time frame: Baseline, Day 14, and Day 28

    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.

  2. Hamilton Anxiety Rating Scale (HAMA) Total Score

    Time frame: Baseline, Day 14, and Day 28

    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.

  3. Autonomic Nervous System Function as Measured by Heart Rate Variability

    Time frame: Baseline, Day28

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiao Chiao Liao

CONTACT

[email protected]

+886 963674763

Sponsors and collaborators

Lead sponsor

Chiao-Chiao Liao

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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