Clinical trial NCT04184362: Empower Opioid Misuse & Chronic Pain
Official title: Empower Opioid Misuse Theranova Study for Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Opioid Use
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity Score Measures
timeFrame: Baseline to Week 3
measure: Opioid Craving Intensity With Empower Neuromodulation Active Treatment Versus Control Treatment
timeFrame: Baseline to Week 3
measure: Mean Morphine Equivalent Doses: Opioid Use With Empower Active Treatment Versus Control Treatment
timeFrame: Baseline to Week 3
Secondary outcomes:
measure: General Health Monitored
timeFrame: Treatment Time Frame: Week 1 to Week 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ellen Herbst, MD
role: PRINCIPAL_INVESTIGATOR
References: