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Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Study acronym: VNS in OUD UH3
StatusRecruiting
PhasePhase 3
Started2024-02-20
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Identification, Study Status, Contacts/Locations v7
Primary completion date2026-10→2027-02
Completion date2026-12→2027-04
Study sites6 entries, revised
Emory UniveristyUniversity
2025-03-06
Study Status, Outcome Measures, Eligibility v6
Eligibility criteria-1 characters
[...] cations that would be contraindicated with hydromorphone or lofexidineclonidine administration History of head trauma resulting in loss of [...]
Secondary endpointsdetails revised at 1 of 12 entries
2024-03-04
Study Status v5
Start dateestimated 2024-02→confirmed 2024-02-20
2024-01-08
Study Status, Eligibility v4
Start date2023-12→2024-02
Eligibility criteria-32 characters
Inclusion Criteria: Meet criteria for OUDs based on the MiniDSM5 International Neuropsychiatric Interview (MINI)criteria Willing to undergo supervised withdrawal Willing to be tran [...] story of schizophrenia, schizoaffective disorder, or bulimia, based on the MINI History of serious medical or neurological illness or organ [...] evice exclusion History of shrapnel or other foreign bodies whichthat would preclude MRI scanning Positive test for COVID-19
2023-11-14
Study Status v3
Start date2023-10-12→2023-12
Show 2 earlier versions
2023-10-11
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03→2026-10
Completion date2026-03→2026-12
Start date2023-09→2023-10-12
Study sites7→6
2023-07-19
Study Status, Eligibility v1
Start date2023-06→2023-09
Eligibility criteria-12 characters
[...] clude PET imaging Active implantable device (i.e. pacemaker) or other VNS device exclusion Carotid atherosclerosis Cervical vagotomy History of shrapnel or other foreign bodies which would preclude MRI scanning
2023-04-14
Original filing
This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.
Trial Details
NCT Number NCT05834478
Lead Sponsor Emory University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Withdrawal Symptoms, Opioid Use Disorder, Opioid Use
Enrollment 103 participants
Start Date 2024-02-20
Primary Completion 2027-02 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-27