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Pilot Research on Opioid Use Disorder

NCT04244227 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-02-21

No results posted yet for this study

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.

Conditions

  • Opioid-use Disorder

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Northern California Institute of Research and Education

    collaborator OTHER

  • Theranova, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Michael Vice President · Theranova, LLC

  • Ellen Principal Investigator · Northern California Institute of Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-02-15
Completion
2022-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04244227 on ClinicalTrials.gov