Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

PHASE3RecruitingINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

February 20, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions
Withdrawal SymptomsOpioid Use DisorderOpioid Use
Interventions
DEVICE

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).

DEVICE

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.

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.

Trial Locations (6)

30322

RECRUITING

Emory University Clinical Research Network, Atlanta

NOT_YET_RECRUITING

Health Sciences Research Building, Atlanta

RECRUITING

Rollins School of Public Health, Atlanta

30329

RECRUITING

12 Executive Park Drive, Atlanta

RECRUITING

Emory Univeristy, Atlanta

30332

RECRUITING

Georgia Institute of Technology, Atlanta

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Emory University

OTHER