Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

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.

Conditions

• Nicotine Dependence
• Nicotine Withdrawal
• Tobacco Use Disorder
• Anxiety
• Mental Disorders

Interventions

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.

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.

Sponsors & Collaborators

• Chiao-Chiao Liao

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-23

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• Taiwan

Study Locations