Nicotine DependenceNCT07466875
Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients
A study testing Auricular acupressure and Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) in people with Nicotine Dependence and Nicotine Withdrawal, run by Chiao-Chiao Liao at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Nicotine Withdrawal, Tobacco Use Disorder
- What is being tested?
- Auricular acupressure and Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tsaotun Psychiatric Center, Ministry of Health and Welfare
Nantou City, 542
Tsaotun Psychiatric Center Ministry of Health and Welfare, +886-4-9255-0800#2091, ttpc@ttpc.mohw.gov.tw
About this study
Official 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
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.
Read more
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.
- Being tested
- Auricular acupressure, Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Sham Auricular Acupressure
- Medical subject headings
- Tobacco Use Disorder, Anxiety Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureDevice
Also called auricular acupuncture, ear seed
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Auricular acupressure; Drug: 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. Receives: Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge); Device: Sham Auricular Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14, Day 28
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start23 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiao-Chiao Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiao-Chiao Liao, TsaoTun Psychiatric Center, Department of Health, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466875
- Sponsor's protocol ID
- 114044
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26892910Zhang 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.
PubMed 24138333Mi 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.
PubMed 39931130
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07466875
- Acronym / sponsor ID
- 114044
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chiao-Chiao LiaoUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure Group | Experimental | Device: Auricular acupressure, Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)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). |
| Sham Auricular Acupressure Group | Sham comparator | Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Device: Sham Auricular AcupressureParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupressureAlso: auricular acupuncture, ear seedParticipants 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. | Device | Auricular Acupressure Group |
| 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. | Drug | Auricular Acupressure Group, Sham Auricular Acupressure Group |
| Sham Auricular AcupressureParticipants 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. | Device | Sham Auricular Acupressure Group |
Primary outcome
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.
3 secondary outcomes
Minnesota Nicotine Withdrawal Scale (MNWS) Total Score
Time frame: Baseline, Day 14, and Day 28
Hamilton Anxiety Rating Scale (HAMA) Total Score
Time frame: Baseline, Day 14, and Day 28
Autonomic Nervous System Function as Measured by Heart Rate Variability
Time frame: Baseline, Day28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 26892910Soyster 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.
- Background: PubMed 24138333Zhang 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.
- Background: PubMed 39931130Mi 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure and Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge) in people with Nicotine Dependence and Nicotine Withdrawal, run by Chiao-Chiao Liao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiao Chiao Liao (+886 963674763, l23ful6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving scale (time frame: Baseline, Day 14, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466875, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.