Pilot Research on Opioid Use Disorder (PROUD)

February 17, 2022 updated by: Theranova, L.L.C.

Pilot Evaluation of the Empower Neuromodulation System in OUD Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Northern California Institute for Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
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
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Sham Comparator: Sham treatment
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
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid craving intensity
Time Frame: 3 weeks
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
Time Frame: 3 weeks
Safety assessment via device-related adverse events.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: 3 weeks
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).
Time Frame: Week one of the 3-week study
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).
Time Frame: Week one of the 3-week study
Change in SOWS score.
Week one of the 3-week study
System usability scale (SUS)
Time Frame: 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranova, L.L.C.

Collaborators

National Institute on Drug Abuse (NIDA)
Northern California Institute of Research and Education

Investigators

  • Study Director: Michael Vice President, TheraNova, LLC
  • Principal Investigator: Ellen Principal Investigator, Northern California Institute of Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Anticipated)

February 15, 2022

Study Completion (Anticipated)

February 15, 2022

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-12-1209-01
  • R43DA049623 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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