Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
VNS in OUD UH3
3 other identifiers
interventional
103
1 country
6
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2024
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
March 27, 2026
March 1, 2026
3 years
March 14, 2023
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score
All participants will complete the Subjective Opiate Withdrawal Scale (SOWS). The total score on each day will be compared between active tcVNS versus sham stimulation. The SOWS is performed four times daily. The total SOWS score is the sum of the individual item scores and ranges from 0 to 64, with a higher score indicating greater withdrawal severity.
Day 2, Day 3
Safety of tcVNS use
Defined as the absence of device related adverse events.
Up to 7 days after study initiation
Secondary Outcomes (12)
Study retention
Baseline, Up to 10 days after study initiation
Treatment adherence
3 months
Change in brain dopamine D1 and D2/3 receptor regional binding potentials
Day 2, Day 3
Change in heart rate
Baseline, Day 2, Day 3
Change in inflammatory biomarkers
15 minutes before stress and up to 180 minutes post-stress
- +7 more secondary outcomes
Study Arms (2)
Transcutaneous Cervical Vagal Nerve Stimulation Device
EXPERIMENTALStimulation with the tcVNS
Sham Stimulation Device
SHAM COMPARATORStimulation with the sham device.
Interventions
\[F-18\]Fallypride is a radioactive material. Each patient will have two \[F-18\]Fallypride PET scans. For each scan \[F-18\]Fallypride will be injected as an intravenous bolus. The radiation dose to body organs in this study is well within the Food and Drug Administration (FDA) national guidelines for radiation exposure for human research studies and less than the total amount that is permitted for research studies in one year.
Participants will receive stimulation of the vagus nerve with the non-invasive transcutaneous cervical Vagal Nerve Stimulation (tcVNS), which does not require surgery or implantation, and electrically stimulates the vagus nerve as it passes through the neck, dampening the sympathetic nervous system and modulating brain regions to a single side of the neck with the GammaCore device. Participants will be trained on self-stimulation and from days 1-7 patients undergo four times daily self-stimulation with tcVNS first for two minutes on one side, followed by a one-minute pause, then two minutes on the same side. The intensity of the stimulus (i.e. the current amplitude) will be adjusted by the user, to the maximum tolerable level without causing excessive pain \[typically 10-30 V and 60milliamperes (mA) (peak)\], with an alternating current (AC) signal consisting of five 5 kilohertz (kHz) pulses 200 microseconds in duration, repeating at a rate of 25 Hz (about once every 40 milliseconds).
Participants will have the same procedures as with the tcVNS but will instead receive a device that appears identical to the active tcVNS device in look, weight, visual and audible feedback, and also in user controls. The Sham device looks and sounds like an active device but does not deliver an electric current.
Eligibility Criteria
You may qualify if:
- Meet criteria for OUDs based on the DSM5 criteria
- Willing to undergo supervised withdrawal
- Willing to be transitioned to a MOUD or behavioral management during treatment aftercare
You may not qualify if:
- Positive pregnancy test or breastfeeding for women
- History of meningitis
- Traumatic brain injury
- Current treatment with methadone, naltrexone, or Suboxone or medications that would be contraindicated with hydromorphone or clonidine administration
- History of head trauma resulting in loss of consciousness (LOC) of greater than one minute where the LOC is not judged to be primarily related to overdose in the judgment of the study physician
- Past year moderate to severe non-opioid use disorders that would require separate withdrawal management
- Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia
- History of serious medical or neurological illness or organic mental disorder, including liver disease, but also including cardiovascular, gastrointestinal, hepatic, renal, neurologic, or other systemic illness, including liver enzymes aspartate transaminase (AST) and alanine transaminase (ALT) more than three times upper limit of normal, that would preclude involvement based on the clinical judgment of the study psychiatrist
- Lack of venous access that would preclude PET imaging
- History of shrapnel or other foreign bodies that would preclude MRI scanning
- Positive test for COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (6)
Emory University Clinical Research Network
Atlanta, Georgia, 30322, United States
Health Sciences Research Building
Atlanta, Georgia, 30322, United States
Rollins School of Public Health
Atlanta, Georgia, 30322, United States
12 Executive Park Drive
Atlanta, Georgia, 30329, United States
Emory University
Atlanta, Georgia, 30329, United States
Georgia Institute of Technology
Atlanta, Georgia, 30332, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D Bremner, MD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 14, 2023
First Posted
April 28, 2023
Study Start
February 20, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
At the conclusion of the trial, the data will be stripped of identifiers prior to release for sharing and will be made available in de-identified form to other investigators and other sites.