Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

Summary

Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. Recruitment will be from treatment programs in the greater Atlanta Metropolitan Region including the DeKalb Community Service Board residential, detoxification and other treatment programs which with over 30,000 patient visits per year represents the largest treatment program in one of two urban counties in greater Atlanta.

This trial involves a second phase after completing an exploratory study in 20 patients with OUDs to assess different timing parameters of nVNS effects on sympathetic measures and symptoms of craving, as well as modelling to verify and iteratively refine the methods for vagal nerve stimulation. The investigators in this trial will then apply nVNS comparing active (N=10) to sham (N=10) in OUD patients recently started on medication, looking at opioid craving, brain functional response with HR-PET, and cardiovascular and inflammatory biomarker responses to imagery-induced opioid drug craving.

Conditions

• Substance-Related Disorders
• Substance Use Disorders
• Substance Abuse, Intravenous
• Substance Withdrawal
• Substance Abuse
• Opioid-use Disorder
• Opioid Use Disorder, Severe
• Opioid 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• City University of New York

  collaborator OTHER

• Georgia Institute of Technology

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• J Douglas Bremner, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-13

Primary Completion

2022-07-27

Completion

2022-09-13

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations