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NOT YET RECRUITING
NCT07899957
NA

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder

Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

View on ClinicalTrials.gov

Summary

The Department of Acupuncture-Moxibustion, the First Affiliated Hospital of Zhejiang Chinese Medical University is conducting a clinical research project entitled "Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (transcutaneous auricular vagus nerve stimulation,taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder". This study aims to explore the short-term clinical efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS), based on the theory of "Heart-Kidney Interplay", in improving insomnia among patients with methamphetamine use disorder in the withdrawal-rehabilitation period on the basis of routine drug-addiction rehabilitation. The primary efficacy outcome is the change in total score of the Insomnia Severity Index (Insomnia Severity Index,ISI) from baseline to Week 4. This project will commence in September 2026, and a total of 96 participants with methamphetamine use disorder in the withdrawal-rehabilitation period will be recruited.

Official title: Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-10-01

Completion Date

2028-05-01

Last Updated

2026-10-28

Healthy Volunteers

No

Conditions

Interventions

DEVICE

taVNS

Stimulation targets: Bilateral auricles were stimulated simultaneously, targeting the bilateral cavum conchae (corresponding to the auricular acupoint "Heart" in traditional Chinese medicine) and cymba conchae (corresponding to the auricular acupoint "Kidney" in traditional Chinese medicine). Stimulation parameters: Frequency: 4/20 Hz dense-sparse wave (alternation of 4 Hz for 5 seconds and 20 Hz for 10 seconds). Pulse width: 0.2 ms ± 30%. Intensity: individually adjusted. At the beginning of each treatment, the current intensity was slowly increased from 0 mA until the participant reported distinct pricking or tingling sensation without pain (0.8-1.5 mA). Treatments were administered twice daily, 30 minutes per session. Treatment was performed 5 consecutive days per week (Monday to Friday), with 2-day rest intervals. The total intervention period was 4 weeks.

DEVICE

sham-taVNS

Stimulating device and appearance: The identical stimulating device and electrodes as those used in the taVNS treatment group were adopted, with exactly the same operating procedures and treatment duration. Stimulation target: The central area of bilateral earlobes. This region is considered to have extremely sparse vagus nerve innervation, and the physiological effects induced by stimulation at this site are negligible. Stimulation parameters: The same device and parameter settings were applied as in the treatment group, while the current intensity was limited to within 0.1 mA. This design aims to make participants unable to distinguish between real and sham stimulation by sensory perception. Treatment regimen: Treatments were delivered twice daily, 30 minutes per session. Treatment was performed for 5 consecutive days each week (Monday to Friday), followed by 2-day rest. The total intervention period was 4 weeks.