Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

July 27, 2022

Study Completion Date

September 13, 2022

Conditions
Substance-Related DisordersSubstance Use DisordersSubstance Abuse, IntravenousSubstance WithdrawalSubstance AbuseOpioid-use DisorderOpioid Use Disorder, SevereOpioid Use
Interventions
DEVICE

Non invasive VN stimulation (nVNS)

"Stimulation of vagus nerve with active device. Participants will be administered nVNS using the electroCore GammaCore-S non-invasive VNS device. The intensity of the stimulus will be adjusted by the user, to the maximum tolerable level to ensure nVNS without causing excessive pain, the burst frequency to 5 kHz, and the envelope frequency to 25 Hz.~The duration of delivery will be 2 minutes, and the beginning will coincide with initiation of acquisition of the HR-PET scan which will be 90 seconds in duration; following an additional 8 minutes, a second VNS delivery will be administered, in conjunction with which another scan will be obtained."

DRUG

Oxygen (15-O) Water

Injection of radiolabelled water. H2\[15-O\] is a radioactive material. Each patient will have eight H2\[15-O\] blood flow scans. For each O-15 water scan 20 mCi of H2\[15O\] will be injected as an intravenous bolus.

DEVICE

Sham Stimulation

"Sham stimulation of vagus during opioid cue exposure. Each subject in the SHAM group will undergo the action of administering the intervention, but the device will be programmed such that the stimulation will not activate the vagus nerve."

Trial Locations (1)

30322

Emory University, Atlanta

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

City University of New York

OTHER

collaborator

Georgia Institute of Technology

OTHER

lead

Emory University

OTHER

NCT04556552 - Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders | Biotech Hunter | Biotech Hunter