Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients
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
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |