drugset / Trial / NCT07466875

Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients

NCT07466875

Recruiting 60 enrolled Chiao-Chiao Liao
RandomizedParallel-groupTriple-blindSupportive care

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.

Timeline

Start
2026-03-23
Primary completion
2027-07-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Background Nicotine Unknown 2 mg
Background Nicotine Unknown 4 mg
Background Nicotine Unknown 7 mg
Background Nicotine Unknown 14 mg
Background Nicotine Unknown 21 mg