Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChiao-Chiao Liao

About this 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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Auricular acupressure
  • Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
  • Sham Auricular Acupressure

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chiao-Chiao Liao

Lead sponsor

TsaoTun Psychiatric Center, Department of Health, Taiwan

Sponsor institution