Pilot Research on Opioid Use Disorder

Study Overview
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Brief Summary
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This study evaluates the effects of peripheral nerve stimulation on opioid withdrawal, craving, and use in participants with opioid use disorder (OUD) who are initiating treatment with buprenorphine/naloxone. This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.

Detailed Description
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Opioid use disorder (OUD) has become a public health emergency. Approximately 2.6 million Americans suffered from OUD in 2016. Evidence-based approaches for treating OUD include several medication-assisted treatments (MATs). While MATs are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are key contributors to treatment dropout, relapse, and overdose. Peripheral nerve stimulation via acupuncture has been shown to directly decrease drug withdrawal, craving, and self-administration. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of OUD. In this study, a randomized, controlled study will be conducted in participants with OUD who are initiating treatment with buprenorphine/naloxone. Participants will self-administer daily treatment with the Empower device. Endpoints will be evaluated for safety, effectiveness, and acceptability.

Official Title
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Pilot Evaluation of the Empower Neuromodulation System in OUD Patients

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Device: Empower Neuromodulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VA-eligible Veterans Ages ≥ 18 Current diagnosis of opioid use disorder per DSM-5 by clinician assessment Scheduled to initiate, or has initiated within the past five days, treatment for OUD with buprenorphine/naloxone Exclusion Criteria: Injury or nerve damage at the arm or palm and/or neuropathy in the upper extremities Pregnant or planning to become pregnant Currently implanted with an electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, 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 History of epilepsy or a seizure disorder Has an electrically conductive metal object (e.g. jewelry) that cannot be removed and will directly contact the gel electrodes of the Empower Neuromodulation System when applied to the skin at the stimulation location Unable to provide informed written consent Has taken a medication-assisted treatment (MAT) for OUD in the past two weeks or plans to take any prescription opioid or MAT for OUD other than buprenorphine/naloxone while enrolled in the study Is deemed unsuitable for enrollment in the study by the PI (e.g. current medical or psychiatric instability)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 3-week study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Participants will self-administer treatment with the Empower device at the active treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower active treatment. | Device: Empower Neuromodulation System<br>* Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.<br>|
| Sham Comparator: Sham treatment<br>Participants will self-administer treatment with the Empower device at the sham treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower sham treatment. | Device: Empower Neuromodulation System<br>* Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid craving intensity | Self-reported opioid craving intensity via daily 100-mm visual-analog scale (VAS). The VAS has a minimum score of 0 (no craving) and a maximum score of 100 (severe craving). | 3 weeks | 
| Adverse events | Safety assessment via device-related adverse events. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Number of positive outcomes in urine screening tests for opioids. | 3 weeks | 
| Clinical opioid withdrawal scale (COWS). The COWS is an 11-item, clinician-administered tool that measures a patient's withdrawal symptoms. The COWS has a minimum score of 0 (no withdrawal) and a maximum score of 48 (severe withdrawal). | Change in COWS score. | Week one of the 3-week study | 
| Subjective opioid withdrawal scale (SOWS). The SOWS is an 16-item, self-reported questionnaire that measures a patient's withdrawal symptoms. The SOWS has a minimum score of 0 (no withdrawal) and a maximum score of 64 (severe withdrawal). | Change in SOWS score. | Week one of the 3-week study | 
| System usability scale (SUS) | Self-reported assessment of system usability. The SUS is a 10-item, self-reported questionnaire that measures usability of the system. The SUS has a minimum score of 0 (extremely poor usability) and a maximum score of 100 (excellent usability). | 3 weeks |