RecruitingPhase 3NCT05834478

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Sponsor

Emory University

Enrollment

103 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Withdrawal Symptoms

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria12

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

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Interventions

DEVICETranscutaneous 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).

DEVICESham 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.

DRUG[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.