The Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals With Tiletamine Use Disorder

NCT07689981 | Not Yet Recruiting DMC

• 1 other identifier: JDu-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tiletamine Use Disorder; Drug Craving; Substance Use Disorder (SUD)

Keywords

taVNS; Addiction; Brain-Heart Coupling; HRV; EEG; Neuromodulation; Drug Craving; Tiletamine Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, immediately after the intervention,one month after the intervention

Secondary Outcomes (16)

• 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,

Study Arms (2)

Active taVNS

EXPERIMENTAL

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

Sham taVNS

SHAM COMPARATOR

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

The stimulation duration is 40 minutes per session, administered four times daily for 5 consecutive days (20 sessions in total).

Active taVNS

Sham Stimulation DEVICE

Identical device appearance and parameters, with minimal sensory stimulation and no vagal activation. The treatment schedule is identical to that of the active group.

Sham taVNS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Jiang Du, M.D, Ph.D

CONTACT

+8618017311220; dujiangdou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)