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Not yet recruiting NCT07689981

The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder

No phase Interventional Tiletamine Use Disorder Substance Use Disorder (SUD) Drug Craving

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation, Sham Stimulation.
Who it may be relevant to
Registry conditions: Tiletamine Use Disorder, Substance Use Disorder (SUD), Drug Craving. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Tiletamine Use Disorder: A Randomized Double-Blind Sham-Controlled Trial

Overview

Participants diagnosed with tiletamine use disorder will be assigned to active or sham taVNS for 5 days. Clinical outcomes ( e.g., behavioral paradigms measures and clinical scales ) and physiological markers (e.g., EEG and ECG) will be evaluated at baseline, post-treatment, and 3-month follow-ups to determine therapeutic efficacy and mechanisms of action.

Detailed description

Tiletamine use disorder has emerged as a significant public health concern characterized by persistent psychological craving and high relapse rates. This randomized, double-blind, sham-controlled clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS) can reduce craving levels and improve other outcomes in individuals with tiletamine dependence. Multimodal assessments including electroencephalography (EEG), electrocardiography (ECG) , behavioral paradigms measures and clinical scales will be conducted before and after the treatment.

This study seeks to establish a non-invasive vagus nerve stimulation strategy for substance use disorders and explore the treatment mechanism.

Interventions

  • Device Transcutaneous Auricular Vagus Nerve Stimulation
    The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total).
  • Device Sham Stimulation
    Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation. The treatment schedule is identical to that of the active group.

Primary outcome measures

  • Change of depressive symptoms [Time frame: Baseline, immediately after the intervention,one month after the intervention]
Secondary outcome measures (12)
  • Change of stress symptoms [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • Change of the sleep quality [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • Change of the anxiety symptoms [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • Change of the risky decision-making performance [Time frame: Baseline, immediately after the intervention]
  • Changes in Negative Reinforcement Learning Behaviour [Time frame: Baseline, immediately after the intervention,]
  • The change of alcohol craving [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • The change of alcohol use [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • The changes of Resilience [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • The condition of childhood experiences [Time frame: Baseline]
  • The change of nicotine dependence [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • Change of the self-control ability [Time frame: Baseline, immediately after the intervention, one month after the intervention,]
  • The changes of impulsive behavior [Time frame: Baseline, immediately after the intervention, one month after the intervention,]

Eligibility criteria

Inclusion criteria

  • Age 18-60 years ≥6 years of education\[7.1\] DSM-5 diagnosis of substance use disorder related to tiletamine Tiletamine use ≥6 months and ≥1 time/week Ability to provide informed consent Willingness to complete follow-up assessments

Exclusion criteria

  • Severe cognitive impairment History of epilepsy, brain injury, neurological disease or serious psychiatric disease Use of cognition-enhancing medications within 6 months Other psychoactive substance abuse within past 5 years (except nicotine) Metal implants in the head or severe skin sensitivity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT07689981 · JDu-019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗