NCT04244227

Pilot Research on Opioid Use Disorder

Pilot Evaluation of the Empower Neuromodulation System in OUD Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DEVICE	Empower Neuromodulation System	Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Timeline

• Start date: 2020-03-10
• Primary completion: 2022-02-15
• Completion: 2022-02-15
• First posted: 2020-01-28
• Last updated: 2022-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study