Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

Conditions

• Opioid Use
• Opioid Use Disorder
• Withdrawal Symptoms

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Transcutaneous Cervical Vagal Nerve Stimulation — DEVICE
  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).
• Sham Stimulation — DEVICE
  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.
• [F-18]Fallypride — DRUG
  \[F-18\]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.

Study Details

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.

Key Dates

Start date

Feb 20, 2024

Status verified

Mar 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

103 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Transcutaneous Cervical Vagal Nerve Stimulation Device
  Stimulation with the tcVNS
• Sham Comparator: Sham Stimulation Device
  Stimulation with the sham device.

Primary Outcome Measure

Change in Peak Subjective Opiate Withdrawal Scale (SOWS) Score [ Time Frame: Day 2, Day 3 ]

Central Contacts

• James D Bremner, MD
  404-712-9569
  [email protected]

Locations (6)

Find similar trials in Atlanta, GA

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