Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

April 6, 2026 updated by: Chiao-Chiao Liao

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Nantou City, Taiwan, 542
        • Recruiting
        • Tsaotun Psychiatric Center, Ministry of Health and Welfare
        • Contact:
          • Tsaotun Psychiatric Center Ministry of Health and Welfare
          • Phone Number: +886-4-9255-0800#2091
          • Email: ttpc@ttpc.mohw.gov.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with active auricular acupressure. Vaccaria seeds will be applied to specific acupuncture points (e.g., Shenmen, Lung, Subcortex).
Device: Auricular acupressure

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
Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
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 Comparator: Sham Auricular Acupressure Group
Participants in this group will receive standard Nicotine Replacement Therapy (NRT) combined with sham auricular acupressure. Sham material with no active stimulation will be applied to specific acupuncture points.
Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
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.
Device: Sham Auricular Acupressure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 14, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 14, and Day 28
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.
Baseline, Day 14, and Day 28
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.
Baseline, Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiao-Chiao Liao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of the psychiatric inpatients and comply with the institutional ethical guidelines, there is no plan to share individual participant data (IPD) with the public. However, the study protocol and the statistical analysis plan may be available upon reasonable request to the corresponding author after the study's completion and publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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