This prospective, randomized, double-blind, parallel-group, sham-controlled, superiority study will evaluate the effectiveness of the NET device in treating persons with Opioid Use Disorder (OUD) without use of Medication treatment for OUD (MOUD) for persons who have expressed a desire to be opioid abstinent without use of MOUD.
The primary study objective is to determine whether use of the NET device increases illicit opioid abstinence without use of MOUD, relative to sham treatment given under the same experimental conditions, in persons meeting DSM-5 criteria for OUD. The NET device is an investigational Non-Significant Risk device that delivers alternating current via surface electrodes placed transcranially on the mastoid regions. All participants will be screened and undergo evaluation at Isaiah House, a treatment center located in Willisburg, KY. Individual participant treatment (duration of the active/sham device use) is 1 hour and extendable by participant choice, but not to exceed 7 days, delivered at the inpatient facility (typically 28 days duration), with weekly follow-up assessments (efficacy and safety endpoints) following discharge (by video) for a 12-week outpatient study period. Total elapsed time will typically be 16 weeks. The primary endpoint is each participant's overall percentage of weekly abstinence from illicit opioid use without use of MOUD, based on negative oral fluid samples and self/pharmacy reports of illicit opioid, methadone, buprenorphine, and naltrexone use per week (unit of analysis) during the 12-week outpatient study period.
| Condition | Opioid Use Disorder |
|---|---|
| Treatment | NET, NET |
| Clinical Study Identifier | NCT04916600 |
| Sponsor | Wayne State University |
| Last Modified on | 7 February 2023 |
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