Clinical trial NCT04244227: Pilot Research on Opioid Use Disorder
Official title: Pilot Evaluation of the Empower Neuromodulation System in OUD Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Northern California Institute of Research and Education
First posted: 2020-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Opioid craving intensity
timeFrame: 3 weeks
measure: Adverse events
timeFrame: 3 weeks
Secondary outcomes:
measure: Opioid use
timeFrame: 3 weeks
measure: 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).
timeFrame: Week one of the 3-week study
measure: 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).
timeFrame: Week one of the 3-week study
measure: System usability scale (SUS)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Northern California Institute for Research and Education
state: California
Study officials:
affiliation: Theranova, LLC
name: Michael Vice President
role: STUDY_DIRECTOR
affiliation: Northern California Institute of Research and Education
name: Ellen Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: