NCT07466875

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

March 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 7, 2026

Last Update Submit

April 6, 2026

Conditions

Nicotine DependenceNicotine WithdrawalTobacco Use DisorderAnxietyMental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Day 14, Day 28

Secondary Outcomes (3)

  • Minnesota Nicotine Withdrawal Scale (MNWS) Total Score

    Baseline, Day 14, and Day 28

  • Hamilton Anxiety Rating Scale (HAMA) Total Score

    Baseline, Day 14, and Day 28

  • Autonomic Nervous System Function as Measured by Heart Rate Variability

    Baseline, Day28

Study Arms (2)

Auricular Acupressure Group

EXPERIMENTAL

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 acupressureDrug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)

Sham Auricular Acupressure Group

SHAM COMPARATOR

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)Device: Sham Auricular Acupressure

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.

Also known as: auricular acupuncture, ear seed
Auricular Acupressure Group
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.

Auricular Acupressure GroupSham Auricular Acupressure Group
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.

Sham Auricular Acupressure Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsaotun Psychiatric Center, Ministry of Health and Welfare

Nantou City, 542, Taiwan

RECRUITING

Related Publications (3)

  • Soyster P, Anzai NE, Fromont SC, Prochaska JJ. Correlates of nicotine withdrawal severity in smokers during a smoke-free psychiatric hospitalization. Prev Med. 2016 Nov;92:176-182. doi: 10.1016/j.ypmed.2016.01.026. Epub 2016 Feb 15.

    PMID: 26892910BACKGROUND

  • Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.

    PMID: 24138333BACKGROUND

  • Mi Q, Zhao X, Zhang Z, Bao F. The effectiveness and safety of auricular acupoint-related therapy for nicotine dependence: A systematic review and meta-analysis. Tob Induc Dis. 2025 Feb 10;23. doi: 10.18332/tid/200550. eCollection 2025.

    PMID: 39931130BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderAnxiety DisordersMental Disorders

Interventions

Acupuncture, EarNicotine Replacement TherapyTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapyDrug Therapy

Central Study Contacts

Chiao Chiao Liao

CONTACT

+886 963674763l23ful6@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident Physician and Principal Investigator

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 12, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

TW(1)