Recruiting
Phase 3

Vagal Nerve Stimulation

Sponsor:

Emory University

Code:

NCT05834478

Conditions

Withdrawal Symptoms

Opioid Use Disorder

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Cervical Vagal Nerve Stimulation

Sham Stimulation

[F-18]Fallypride

Study Details

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.

Conditions

Withdrawal Symptoms

Opioid Use Disorder

Opioid Use

Study ID

NCT05834478

Start date

Feb 20, 2024

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active implantable device (i.e. pacemaker) or other VNS device exclusion
  • History of shrapnel or other foreign bodies that would preclude MRI scanning
  • Positive test for COVID-19

Study Design

Enrollment

103 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcutaneous Cervical Vagal Nerve Stimulation Device

Stimulation with the tcVNS

sham comparator: Sham Stimulation Device

Stimulation with the sham device.

Interventions

Transcutaneous Cervical Vagal Nerve Stimulation

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).

Sham Stimulation

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.

[F-18]Fallypride

\[F-18\]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.

Primary outcome measure

  • Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score [ Time Frame: Day 2, Day 3 ]
  • Safety of tcVNS use [ Time Frame: Up to 7 days after study initiation ]

Central Contacts and Locations

Central contacts

James D Bremner, MD

404-712-9569jdbremn@emory.edu

Locations

Emory University Clinical Research Network

Recruiting

Atlanta, Georgia, United States, 30322

Rollins School of Public Health

Recruiting

Atlanta, Georgia, United States, 30322

12 Executive Park Drive

Recruiting

Atlanta, Georgia, United States, 30329

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Georgia Institute of Technology

Recruiting

Atlanta, Georgia, United States, 30332

More Information

Sponsor

Emory University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Non-invasive Vagal Nerve Stimulation
  • Vagus nerve
  • vagus nerve stimulation
  • OUD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-27.