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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulation

    Device

    The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total).

  • Sham Stimulation

    Device

    Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation. The treatment schedule is identical to that of the active group.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Active taVNSExperimental treatment 1 intervention
Group B: Sham taVNSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of depressive symptoms

The PHQ-9, fully known as the Patient Health Questionnaire-9, is a self-report assessment tool developed based on the diagnostic criteria in the American Diagnostic and Statistical Manual of Mental Disorders for screening and evaluating the severity of depression. The scale consists of nine items corresponding to the core symptoms of depression. Respondents rate the frequency of symptoms experienced over the past two weeks on a scale of 0 to 3. The total score ranges from 0 to 27, with higher scores indicating potentially more severe depressive symptoms.

Time frame
Baseline, immediately after the intervention,one month after the intervention

Secondary outcomes

1

Change of stress symptoms

PSS stands for the Perceived Stress Scale. It is used to assess an individual's subjective perceptions of stress and the frequency of stress-related thoughts and feelings over the past month. The scale consists of 14 items, with derived 10-item and 4-item versions also available, and uses a five-point scoring system from 0 to 4, ranging from "never" to "very often". It provides a quick measure of an individual's perceived stress level. The total score ranges from 0 to 56, corresponding to three stress levels: normal (0-28), elevated (29-42), and high (43-56). The scale helps identify stress status and provides guidance for adjusting support resources.

Time frame
Baseline, immediately after the intervention, one month after the intervention,
2

Change of the sleep quality

Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). The total score of PSQI ranges from 0 to 21, in which higher scores mean poorer sleep quality.

Time frame
Baseline, immediately after the intervention, one month after the intervention,
3

Change of the anxiety symptoms

The GAD-7 is a self-report scale for assessing anxiety symptoms. It consists of seven items assessing: 1. nervousness or anxiety; 2. uncontrollable worry; 3. excessive worry; 4. difficulty relaxing; 5. restlessness; 6. irritability; and 7. a sense of imp

Time frame
Baseline, immediately after the intervention, one month after the intervention,
4

Change of the risky decision-making performance

Risky decision-making performance will be assessed using the Balloon Analogue Risk Task (BART). Higher average pumps in the BART indicate greater risk-taking propensity. Electroencephalography (EEG) will be used to measure neural electrical signals, where increases in relevant electrophysiological indicators may reflect heightened individual sensitivity to negative feedback. Higher frequency of continued dice rolls indicates greater risk propensity. Neural activity features related to the task will be analyzed, with specific patterns associated with risk evaluation and reward processing.

Time frame
Baseline, immediately after the intervention

Other outcomes

Sponsors and contacts

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