Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): Auricular Acupressure Group (experimental) and Sham Auricular Acupressure Group (sham comparator).

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).

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.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: presence of severe skin infection, open wounds, or lesions on the auricle (outer ear); pregnant or breastfeeding women; history of receiving auricular therapy for smoking cessation within the past three months.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-03-23 with completion listed for 2027-07-31.

It ran at 1 site in Taiwan.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Craving scale (time frame: Baseline, Day 14, Day 28).

It also tracked 3 secondary outcomes, for example Minnesota Nicotine Withdrawal Scale (MNWS) Total Score, Hamilton Anxiety Rating Scale (HAMA) Total Score and Autonomic Nervous System Function as Measured by Heart Rate Variability.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.