Pilot Research on Opioid Use Disorder
(PROUD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEllen Principal Investigator

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Theranova, L.L.C.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ellen Principal Investigator

Principal Investigator

Northern California Institute of Research and Education

Michael Vice President

Principal Investigator

Theranova, LLC

Eligibility Criteria

Inclusion Criteria

VA-eligible Veterans

Ages ≥ 18

Current diagnosis of opioid use disorder per DSM-5 by clinician assessment

See 1 more

Treatment Details

Interventions

Empower Neuromodulation System (Neuromodulation)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatmentExperimental Treatment1 Intervention

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.

Group II: Sham treatmentPlacebo Group1 Intervention

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.