Pilot Research on Opioid Use Disorder

NCT04244227 | Active Not Recruiting FDA Device

• 2 other identifiers: CRD-12-1209-01R43DA049623
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Opioid use

  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).

  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).

  Week one of the 3-week study

• System usability scale (SUS)

  3 weeks

Study Arms (2)

Active treatment

EXPERIMENTAL

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

Sham treatment

SHAM COMPARATOR

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

Interventions

Empower Neuromodulation System DEVICE

Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Active treatment; Sham treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Northern California Institute of Research and Education: collaborator

Study Sites (1)

Northern California Institute for Research and Education

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Vice President

  Theranova, LLC

  STUDY DIRECTOR

• Ellen Principal Investigator

  Northern California Institute of Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Research staff will not provide any details that would cause participants to become unblinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 3-week study.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: March 10, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)