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The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder (taVNS-Tiletami)

1 juli 2026 bijgewerkt door: Shanghai Mental Health Center

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Shanghai Mental Health Center
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active taVNS
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation Stimulation site: Left cymba conchae Frequency: 20 Hz Pulse width: 500 μs Intensity: 0.5-4 mA (perceptible but non-painful) Session duration: 40 minutes Frequency: 4 sessions/day Treatment course: 5 days (20 sessions)
Apparaat: 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).
Sham-vergelijker: Sham taVNS
Intervention: Sham Stimulation Site: Ipsilateral earlobe Same device appearance and parameters Minimal sensory stimulation without vagal activation Same treatment schedule as active group
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of depressive symptoms
Tijdsspanne: Baseline, immediately after the intervention,one month after the intervention
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.
Baseline, immediately after the intervention,one month after the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change of stress symptoms
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
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.
Baseline, immediately after the intervention, one month after the intervention,
Change of the sleep quality
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
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.
Baseline, immediately after the intervention, one month after the intervention,
Change of the anxiety symptoms
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
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
Baseline, immediately after the intervention, one month after the intervention,
Change of the risky decision-making performance
Tijdsspanne: Baseline, immediately after the intervention
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.
Baseline, immediately after the intervention
Changes in Negative Reinforcement Learning Behaviour
Tijdsspanne: Baseline, immediately after the intervention,
A negative reinforcement learning paradigm was used to assess avoidance-reversal learning behaviour. Behavioural response bias and learning rate were used to characterise negative reinforcement behavioural traits and negative reinforcement learning ability. EEG was recorded simultaneously, and changes in relevant electrophysiological indicators may serve as electrophysiological markers of changes in negative reinforcement learning behaviour.
Baseline, immediately after the intervention,
The change of alcohol craving
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
Alcohol craving will be measured by the alcohol craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of alcohol craving.
Baseline, immediately after the intervention, one month after the intervention,
The change of alcohol use
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The AUDIT (the Alcohol Use Disorders Identification Test) consists of 10 items covering drinking frequency, alcohol consumption, alcohol dependence-related symptoms, and adverse consequences caused by alcohol use. Respondents complete the questionnaire based on their recent drinking behaviour, with each item scored according to different response levels. The total score ranges from 0 to 40. Higher scores indicate a higher risk of alcohol-related problems, and the scale can be used to identify hazardous drinking, harmful drinking, and potential risk of alcohol dependence.
Baseline, immediately after the intervention, one month after the intervention,
The changes of Resilience
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The China version of the Connor-Davidson Resilience Scale (CD-RISC) consists of 25 items and includes three dimensions: tenacity (13 items), strength (8 items), and optimism (4 items). The scale uses a 5-point Likert scoring method, with scores from 0 to 4 representing "not true at all", "rarely true", "sometimes true", "often true", and "true nearly all the time", respectively. The total score ranges from 0 to 100, with higher scores indicating greater psychological resilience. The internal consistency coefficient of the Chinese version is 0.91.
Baseline, immediately after the intervention, one month after the intervention,
The condition of childhood experiences
Tijdsspanne: Baseline
Adverse Childhood Experiences (ACEs) includes 25 clinical items and 3 validity items. The scale uses a 5-point scoring system, ranging from "never true" to "very often true". Each subscale score ranges from 5 to 25 and is calculated by summing the scores of the items within that subscale. The total CTQ score is calculated by summing the subscale scores. Higher scores indicate more severe reported childhood maltreatment.
Baseline
The change of nicotine dependence
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The FTND is a self-report scale used to assess the severity of nicotine dependence among smokers. The scale usually consists of six items. The total score ranges from 0 to 10, with higher scores indicating more severe nicotine dependence. It can be used to assess the level of smoking addiction and support the development of smoking cessation interventions.
Baseline, immediately after the intervention, one month after the intervention,
Change of the self-control ability
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
Self-control ability will be measured using the Self-Control Scale (SCS). Higher scores of SCS indicate better self-regulation and impulse control.
Baseline, immediately after the intervention, one month after the intervention,
The changes of impulsive behavior
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
UPPS-P Impulsive Behavior Scale (UPPS-P) includes 59 items rated on a 4-point Likert scale. Respondents indicate their agreement or disagreement with statements using a 4-point scale (1 = Agree Strongly, 4 = Disagree Strongly). Scoring involves calculating a mean score for each of the five subscales (scaled 1-4) and a total impulsivity score.
Baseline, immediately after the intervention, one month after the intervention,
The changes of morningness-eveningness
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The Chinese version of the 5-item Morningness-Eveningness Questionnaire (rMEQ-5). The Chinese version of the MEQ-5 consists of five items selected from the Chinese version of the MEQ-19, namely items 1, 7, 10, 18, and 19.
Baseline, immediately after the intervention, one month after the intervention,
The change of impulsiveness
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The Barratt Impulsiveness Scale (BIS) consists of 30 items. Each item is rated according to the frequency of occurrence using a 4-point scoring method: rarely/never = 1, occasionally = 2, often = 3, and almost always/always = 4.
Baseline, immediately after the intervention, one month after the intervention,
The change of somatic symptom
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The Somatic Symptom Scale (SSS) consists of 20 items and is a self-report scale using a 4-point rating system (Table 1). A total raw score above 40 is considered positive.
Baseline, immediately after the intervention, one month after the intervention,
The change of behavioral inhibition/activation
Tijdsspanne: Baseline, immediately after the intervention, one month after the intervention,
The Behavioral Inhibition/Activation System Scale (BIS/BAS Scale) uses a 4-point scoring system, where 1 indicates "strongly agree" and 4 indicates "strongly disagree". Higher scores indicate greater activation of the behavioral inhibition system and behavioral activation system.
Baseline, immediately after the intervention, one month after the intervention,

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Mental Health Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • JDu-019

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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