An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation and Sham Stimulation in Tiletamine Use Disorder, Substance Use Disorder (SUD) and Drug Craving, sponsored by Shanghai Mental Health Center. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 30 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Intervention: Sham Stimulation Site: Ipsilateral earlobe Same device appearance and parameters Minimal sensory stimulation without vagal activation Same treatment schedule as active group
Device: Sham Stimulation
The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total).
Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation. The treatment schedule is identical to that of the active group.
Change of depressive symptoms
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.
Time frame: Baseline, immediately after the intervention,one month after the intervention
Change of stress symptoms
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
Change of the sleep quality
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
Change of the anxiety symptoms
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
Time frame: Baseline, immediately after the intervention, one month after the intervention,
Change of the risky decision-making performance
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.
Time frame: Baseline, immediately after the intervention
Changes in Negative Reinforcement Learning Behaviour
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.
Time frame: Baseline, immediately after the intervention,
The change of alcohol craving
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The change of alcohol use
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The changes of Resilience
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The condition of childhood experiences
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.
Time frame: Baseline
The change of nicotine dependence
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
Change of the self-control ability
Self-control ability will be measured using the Self-Control Scale (SCS). Higher scores of SCS indicate better self-regulation and impulse control.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The changes of impulsive behavior
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The changes of morningness-eveningness
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The change of impulsiveness
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The change of somatic symptom
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
The change of behavioral inhibition/activation
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.
Time frame: Baseline, immediately after the intervention, one month after the intervention,
Plan to share: No
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Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 17 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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