The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder (taVNS-Tiletami)
1 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jiang Du, M.D, Ph.D
- Número de telefone: +8618017311220
- E-mail: dujiangdou@163.com
Locais de estudo
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200030
- Shanghai Mental Health Center
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Contato:
- Jiang Du, M.D, Ph.D
- Número de telefone: +86 021 6490 6315
- E-mail: dujiangdou@163.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of depressive symptoms
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of stress symptoms
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
1 de janeiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
1 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de julho de 2026
Primeira postagem (Real)
8 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- JDu-019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .