Summary

for people ages 18-75 (full criteria)
healthy people welcome
at UCSF
study started
estimated completion
Ellen Herbst, MD(ucsf)

Description

Summary

This study evaluates the effects of peripheral nerve stimulation on opioid craving and use and pain in participants with chronic non-cancer pain (NCP) and opioid misuse. Participants will be randomized to receive the active or sham control treatment for the duration of the study.

Official Title

Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain

Details

This pilot study aims to examine the feasibility, acceptability, and preliminarily examine efficacy of peripheral nerve stimulation with the Empower Neuromodulation System on reducing opioid craving and use and decreasing pain. Opioid prescribing for chronic pain has increased dramatically over the past several decades, with devastating public health consequences, including high rates of opioid misuse and overdose deaths. Safe nonpharmacological treatments are urgently needed. In this randomized, controlled study, thirty Veterans with chronic non-cancer pain (NCP) and opioid misuse will be recruited and randomly assigned (1:1) to either the Active or Control treatment. On Days 1-7, participants will undergo baseline monitoring, and on Days 8-21, participants will undergo daily nerve stimulation treatment. Pain scores, craving, and opioid use will be measured daily Days 0-21. Our goal is to provide an intervention that, alone or in conjunction with current treatments, reduces craving and reduces reliance on opioids in high-risk chronic pain patients.

Keywords

Chronic Pain Opioid Use Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation

Eligibility

You can join if…

Open to people ages 18-75

  • VA-eligible Veterans
  • Ages 18-75
  • Currently prescribed and taking chronic opioids (≥90 days dispensed in past 12 months) for non-malignant, non-palliative pain
  • Current (past 12 months) opioid misuse, defined as opioid use not as prescribed. Participants with COMM ≥ 9, SOAPP-R ≥ 18, and/or medical and pharmacy records reflective of opioid misuse in the past 12 months.

You CAN'T join if...

  • Injury or damage to the ulnar nerve, and/or neuropathy in the upper extremities
  • Pregnant or planning to become pregnant
  • Currently implanted with an electrical and/or neurostimulator device, including cardiac pacemaker or defibrillator, vagal neuro-stimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant
  • Use of an investigational drug/device therapy within the past 4 weeks
  • Current medical or psychiatric instability as determined by the participant's primary care provider and/or study PI
  • Severe opioid use disorder (OUD) requiring medication-assisted therapy (buprenorphine, methadone, or naltrexone IM) for OUD
  • Injury or nerve damage at the arm or palm that prevents safe use of Empower device at either site
  • Unable to provide informed written consent
  • Prone to epilepsy or seizures

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientist

  • Ellen Herbst, MD (ucsf)
    Associate Professor, Psychiatry. Authored (or co-authored) 12 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04184362
Study Type
Interventional
Last Updated