Journal Articles

Publication Date



Contemporary Clinical Trials Communications


BACKGROUND: There is an unmet need for non-medication approaches to illicit opioid discontinuation and relapse prevention. The NET (NeuroElectric Therapy) Device is a non-invasive, battery-operated, portable, re-useable device designed to deliver bilateral transcranial transcutaneous alternating current electrical stimulation, and is intended to treat opioid use disorder (OUD) without medication. The device is a CE-marked Class IIa, non-significant risk, investigational medical device.

OBJECTIVE: This prospective trial (NRC021) tests the hypothesis that the NET Device provides safe and effective neurostimulation treatment for persons with OUD who express a desire to be opioid abstinent without medications for opioid use disorder (MOUD).

METHODS: NRC021 is a randomized, parallel-group, sham-controlled, quintuple-blinded, single-site study. Persons with OUD entering a residential treatment facility for opioid detoxification are assigned to active or sham treatment (n = 50/group). Group assignment is stratified on presence of any current non-opioid substance use disorder and by sex. The biostatistician maintains the blinding so that the study sponsor, principal investigator, research assistants, treatment staff, and participants remain blinded. Following discharge from the inpatient facility, participants are assessed once weekly over 12 weeks for substance use (using timeline followback interview and video assessment of observed oral fluid sample provision and testing). The primary efficacy endpoint is each participant's overall percentage of weekly abstinence from illicit opioid use without use of MOUD. The secondary efficacy endpoint is each participant's percentage of non-opioid drug-free weeks. Safety outcomes are also measured.

CONCLUSION: NRC021 is designed to assess the efficacy of a novel non-medication treatment for OUD.

CLINICAL TRIAL REGISTRATION: with the identifier NCT04916600.


Craving, Detoxification, Medications, Opioid use disorder, Transcranial electrical stimulation, Withdrawal

Included in

Public Health Commons



To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.