NET Device for Treating Opioid Use Disorder

  • STATUS
    Recruiting
  • End date
    Dec 2, 2022
  • participants needed
    100
  • sponsor
    Wayne State University
Updated on 2 January 2022

Summary

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.

Description

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.

Details
Condition Opioid Use Disorder
Treatment NET, NET
Clinical Study IdentifierNCT04916600
SponsorWayne State University
Last Modified on2 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study (including inpatient stay and participation in video assessments and remote drug screens for the duration of the 12-week outpatient study period)
Stated desire to be opioid abstinent without medications for treating opioid use disorder
Male or female, aged 18-65 years
In good general health as evidenced by medical history
Meet Diagnostic and Statistical Manual (DSM)-5 criteria for opioid use disorder (any severity level) alone or comorbid with stable medical diseases (except for certain medications below)
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method for the duration of the study
Initiating opioid discontinuation at Isaiah House
Clinical Opiate Withdrawal Scale (COWS) total score is 13 or greater

Exclusion Criteria

Acute/unstable illness: conditions making it unsafe to participate
Chronic illnesses: primarily seizures and dementing illnesses, including medications for these neurological conditions
Current serious psychiatric disease: psychosis, bipolar disorder
Severe SUD for any non-opioid psychoactive substance
Current use of anxiolytics, hypnotics (prescription and over the counter), antidepressants, anticonvulsants, sedating histamine-1 receptor subtype antihistamines (non-sedating second generation histamine-4 receptor subtype antihistamines are allowed), prescription and over the counter stimulants. Benzodiazepine use should be tapered prior to admission
Current diagnosis other than opioid use disorder requiring chronic opioid treatment
Presence of a cardiac pacemaker
Pregnancy or lactation. Females who do not agree to sexual abstinence or are heterosexually active and not using (self-report) medically approved birth control measures (sterilization, tubal ligation, oral/depot contraceptives, abstinence, intrauterine device, barrier method such as condom/foam, or a cervical cap combined with a spermicide), are not eligible
Receiving medication-assisted treatment for opioid use disorder within 90 days of enrollment
Receiving extended-release buprenorphine (Sublocade) within 300 days of enrollment
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