The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder (taVNS-Tiletami)
1 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jiang Du, M.D, Ph.D
- Número de teléfono: +8618017311220
- Correo electrónico: dujiangdou@163.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Mental Health Center
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Contacto:
- Jiang Du, M.D, Ph.D
- Número de teléfono: +86 021 6490 6315
- Correo electrónico: dujiangdou@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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)
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The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total).
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Comparador falso: 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
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Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation.
The treatment schedule is identical to that of the active group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change of depressive symptoms
Periodo de tiempo: Baseline, immediately after the intervention,one month after the intervention
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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.
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Baseline, immediately after the intervention,one month after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change of stress symptoms
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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Change of the sleep quality
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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Change of the anxiety symptoms
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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
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Baseline, immediately after the intervention, one month after the intervention,
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Change of the risky decision-making performance
Periodo de tiempo: Baseline, immediately after the intervention
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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.
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Baseline, immediately after the intervention
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Changes in Negative Reinforcement Learning Behaviour
Periodo de tiempo: Baseline, immediately after the intervention,
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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.
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Baseline, immediately after the intervention,
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The change of alcohol craving
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The change of alcohol use
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The changes of Resilience
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The condition of childhood experiences
Periodo de tiempo: Baseline
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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.
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Baseline
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The change of nicotine dependence
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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Change of the self-control ability
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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Self-control ability will be measured using the Self-Control Scale (SCS).
Higher scores of SCS indicate better self-regulation and impulse control.
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Baseline, immediately after the intervention, one month after the intervention,
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The changes of impulsive behavior
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The changes of morningness-eveningness
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The change of impulsiveness
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The change of somatic symptom
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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The change of behavioral inhibition/activation
Periodo de tiempo: Baseline, immediately after the intervention, one month after the intervention,
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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.
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Baseline, immediately after the intervention, one month after the intervention,
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2026
Publicado por primera vez (Actual)
8 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JDu-019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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