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

1 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200030
        • Shanghai Mental Health Center
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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)
Dispositivo: 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).
Comparatore fittizio: 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
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of depressive symptoms
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of stress symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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,

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Mental Health Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

8 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • JDu-019

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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