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Pilot Research on Opioid Use Disorder (PROUD)

T

TheraNova

Status

Active, not recruiting

Conditions

Opioid-use Disorder

Treatments

Device: Empower Neuromodulation System

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT04244227
CRD-12-1209-01
R43DA049623 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

Active treatment
Experimental group
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.
Treatment:
Device: Empower Neuromodulation System
Sham treatment
Sham Comparator group
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.
Treatment:
Device: Empower Neuromodulation System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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