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Pilot Research on Opioid Use Disorder (PROUD)

Primary Purpose

Opioid-use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empower Neuromodulation System
Sponsored by
Theranova, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Northern California Institute for Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active treatment

Sham treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
Adverse events
Safety assessment via device-related adverse events.

Secondary Outcome Measures

Opioid use
Number of positive outcomes in urine screening tests for opioids.
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.
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.
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).

Full Information

First Posted
January 23, 2020
Last Updated
February 17, 2022
Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Drug Abuse (NIDA), Northern California Institute of Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT04244227
Brief Title
Pilot Research on Opioid Use Disorder
Acronym
PROUD
Official Title
Pilot Evaluation of the Empower Neuromodulation System in OUD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
Collaborators
National Institute on Drug Abuse (NIDA), Northern California Institute of Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Research staff will not provide any details that would cause participants to become unblinded to the treatment groups.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Empower Neuromodulation System
Intervention Description
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
Primary Outcome Measure Information:
Title
Opioid craving intensity
Description
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).
Time Frame
3 weeks
Title
Adverse events
Description
Safety assessment via device-related adverse events.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Opioid use
Description
Number of positive outcomes in urine screening tests for opioids.
Time Frame
3 weeks
Title
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).
Description
Change in COWS score.
Time Frame
Week one of the 3-week study
Title
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).
Description
Change in SOWS score.
Time Frame
Week one of the 3-week study
Title
System usability scale (SUS)
Description
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).
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vice President
Organizational Affiliation
Theranova, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ellen Principal Investigator
Organizational Affiliation
Northern California Institute of Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern California Institute for Research and Education
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Research on Opioid Use Disorder

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