Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Patients With Tiletamine Use Disorder: A Randomized Double-Blind Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of depressive symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of depressive symptoms
时间窗: 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.
次要结局
- The condition of childhood experiences(Baseline)
- Change of stress symptoms(Baseline, immediately after the intervention, one month after the intervention,)
- Change of the sleep quality(Baseline, immediately after the intervention, one month after the intervention,)
- Change of the anxiety symptoms(Baseline, immediately after the intervention, one month after the intervention,)
- Change of the risky decision-making performance(Baseline, immediately after the intervention)
- Changes in Negative Reinforcement Learning Behaviour(Baseline, immediately after the intervention,)
- The change of alcohol craving(Baseline, immediately after the intervention, one month after the intervention,)
- The change of alcohol use(Baseline, immediately after the intervention, one month after the intervention,)
- The changes of Resilience(Baseline, immediately after the intervention, one month after the intervention,)
- The change of nicotine dependence(Baseline, immediately after the intervention, one month after the intervention,)
- Change of the self-control ability(Baseline, immediately after the intervention, one month after the intervention,)
- The changes of impulsive behavior(Baseline, immediately after the intervention, one month after the intervention,)
- The changes of morningness-eveningness(Baseline, immediately after the intervention, one month after the intervention,)
- The change of impulsiveness(Baseline, immediately after the intervention, one month after the intervention,)
- The change of somatic symptom(Baseline, immediately after the intervention, one month after the intervention,)
- The change of behavioral inhibition/activation(Baseline, immediately after the intervention, one month after the intervention,)