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

Sponsor
Shanghai Mental Health Center
Study ID
NCT07689981
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • Sham Comparator: 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

Primary Outcome Measure

Change of depressive symptoms [ Time Frame: Baseline, immediately after the intervention,one month after the intervention ]

Central Contacts

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