Empower Opioid Misuse & Chronic Pain
CompletedNot applicableNCT04184362
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain
- Conditions
- Interventions
- Device: Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation
- Sponsor
- University of California, San Francisco
- Start date
- 2019-11-20
- Primary completion
- 2022-03-21
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04184362