RECRUITING

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Conditions

Withdrawal Symptoms Opioid Use Disorder Opioid Use Non-invasive Vagal Nerve Stimulation Vagus nerve vagus nerve stimulation OUD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Quick Facts

Study Start:2024-02-20

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05834478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 lofexidine 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

Inclusion Criteria

Exclusion 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

* 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 lofexidine 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

Contacts and Locations

Study Contact

James D Bremner, MD

CONTACT

404-712-9569

jdbremn@emory.edu

Principal Investigator

James D Bremner, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

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 Univeristy

Atlanta, Georgia, 30329

United States

Georgia Institute of Technology

Atlanta, Georgia, 30332

United States

Collaborators and Investigators

Sponsor: Emory University

James D Bremner, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-02-20

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Withdrawal Symptoms
Opioid Use Disorder
Opioid Use