A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence
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 cur...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-12-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001351 |
| _version_ | 1811184571464548352 |
|---|---|
| author | Mark K. Greenwald Samiran Ghosh Joe R. Winston |
| author_facet | Mark K. Greenwald Samiran Ghosh Joe R. Winston |
| author_sort | Mark K. Greenwald |
| collection | DOAJ |
| description | 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: ClinicalTrials.gov with the identifier NCT04916600. |
| first_indexed | 2024-04-11T13:15:38Z |
| format | Article |
| id | doaj.art-2e934f8d64f845baae165956b5f23be9 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-11T13:15:38Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-2e934f8d64f845baae165956b5f23be92022-12-22T04:22:25ZengElsevierContemporary Clinical Trials Communications2451-86542022-12-0130101018A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinenceMark K. Greenwald0Samiran Ghosh1Joe R. Winston2Department of Psychiatry and Behavioral Neurosciences, Wayne State University, Detroit, MI, USA; Corresponding author. Department of Psychiatry and Behavioral Neurosciences, Tolan Park Medical Building, 3901 Chrysler Service Drive, Suite 2A, Detroit, MI, 48201, USA.Department of Biostatistics and Data Science, University of Texas School of Public Health, Houston, TX, USANET Recovery Corp. (NRC), Wilmington, DE, USABackground: 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: ClinicalTrials.gov with the identifier NCT04916600.http://www.sciencedirect.com/science/article/pii/S2451865422001351Opioid use disorderDetoxificationWithdrawalCravingTranscranial electrical stimulationMedications |
| spellingShingle | Mark K. Greenwald Samiran Ghosh Joe R. Winston A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence Contemporary Clinical Trials Communications Opioid use disorder Detoxification Withdrawal Craving Transcranial electrical stimulation Medications |
| title | A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence |
| title_full | A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence |
| title_fullStr | A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence |
| title_full_unstemmed | A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence |
| title_short | A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence |
| title_sort | randomized sham controlled quintuple blinded trial to evaluate the net device as an alternative to medication for promoting opioid abstinence |
| topic | Opioid use disorder Detoxification Withdrawal Craving Transcranial electrical stimulation Medications |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001351 |
| work_keys_str_mv | AT markkgreenwald arandomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence AT samiranghosh arandomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence AT joerwinston arandomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence AT markkgreenwald randomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence AT samiranghosh randomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence AT joerwinston randomizedshamcontrolledquintupleblindedtrialtoevaluatethenetdeviceasanalternativetomedicationforpromotingopioidabstinence |