Back to resultsNET Device for Treating Opioid Use Disorder
Primary Purpose
Opioid Use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NET
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder
Eligibility Criteria
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.
- Requiring detoxification from alcohol or benzodiazepines.
- 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.
- 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 extended-release buprenorphine (Sublocade) within 300 days of enrollment.
Sites / Locations
- Isaiah House Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
NET active
NET sham
Arm Description
Active, non-invasive, alternating current transcutaneous stimulation through electrodes placed transcranially on the mastoid regions. Treatment is self-administered, with participant control of device output level and duration according to perceived benefit. Minimum treatment duration is one-hour, with self-administered extension not to exceed 7 days.
Sham, non-invasive, stimulation through electrodes placed transcranially on the mastoid regions. Treatment is self-administered, with participant control of device output level and duration according to perceived benefit. Minimum treatment duration is one-hour, with self-administered extension not to exceed 7 days.
Outcomes
Primary Outcome Measures
Clinically meaningful decrease in opioid withdrawal symptom severity
15% or greater reduction in total score on the Clinical Opiate Withdrawal Scale (COWS); scores range from 0 to 48, with higher scores indicating more severe withdrawal
Secondary Outcome Measures
Comparison of decrease in opioid withdrawal symptom severity between active and sham device treatment
Difference in the magnitude of reduction in total score on the Clinical Opiate Withdrawal Scale (COWS) between active and sham groups; scores range from 0 to 48, with higher scores indicating more severe withdrawal
Comparison of illicit opioid abstinence and no medications for treating opioid use disorder
Difference between active and sham groups in the number of outpatient follow-up weeks with no illicit opioid use and no use of medications for treating opioid use disorder (based on weekly timeline followback interview and oral fluid drug tests)
Rate of adverse events
All adverse events including dermal rash, inflammation, or other adverse events from use of the device
Full Information
NCT ID
NCT04916600
First Posted
June 3, 2021
Last Updated
October 17, 2023
Sponsor
Wayne State University
Collaborators
NET Recovery Corp, Isaiah House
1. Study Identification
Unique Protocol Identification Number
NCT04916600
Brief Title
NET Device for Treating Opioid Use Disorder
Official Title
NET Device as a Non-Pharmacological Alternative to Medication for Opioid Withdrawal Symptom Reduction and Abstinence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
July 7, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
NET Recovery Corp, Isaiah House
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 Medications for OUD (MOUD) for persons who have expressed a desire to be opioid abstinent without use of MOUD.
Detailed Description
The primary study objective is to determine whether use of the active NET Device produces a clinically meaningful decrease in opioid withdrawal symptom severity from baseline to 1-hour in persons with OUD experiencing moderate or greater symptoms of opioid withdrawal.
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 study endpoint is a clinically meaningful decline in COWS total score (defined as a ≥15% reduction) from baseline to 1-hour after start of active NET stimulation.
The first secondary endpoint is a comparison of the decrease in COWS total scores from baseline to 1-hour after start of intervention for active vs sham.
The second secondary efficacy endpoint is a comparison of the percentage of weeks of abstinence from illicit opioid use without the use of MOUD for active vs sham over 12 outpatient weeks following discharge from residential care.
The secondary safety endpoint is the prevalence of all adverse events (AEs) and serious adverse events (SAEs) assessed from day 1 baseline to the end of study, and adverse device effects (ADEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), and device deficiencies assessed from day 1 baseline to end of day 7.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is prospective, randomized, double-blind, parallel-group, sham-controlled and superiority in design. Study enrollees will be assigned in equal proportions (1:1) to one of two groups: active or sham treatment. Group assignment will be stratified by sex. The biostatistician will perform stratified randomization to maintain balance between active and sham groups. The biostatistician will maintain the blinding so that the study sponsor, PI, study monitor, research assistants, treatment staff, and the participants remain blinded. No interim analysis is planned.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sham controls for placebo effects, and is designed to minimize sham recognition by participants, research, and treatment personnel. Active and sham arms will receive identical device care and use instructions, equipment, and attachment locations. Visual cues from the device "heartbeat" indicator (light-emitting diode) indicate the device is working. Sham and active both use the NET device without alteration. Sham uses a lead wire rendered non-conductive beforehand, preventing electrical stimulation. The biostatistician will randomly and uniquely assign a pre-printed Study Device Number (SDN) to each lead wire by overlaying a heat shrink tube, pre-printed with a unique SDN, recording the active and sham assignments. Lead wires are inserted into the device. The biostatistician will keep the data in a secure database and will not be involved in recruitment or study procedures. Unblinding will only occur when necessary for treating an adverse event.
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NET active
Arm Type
Experimental
Arm Description
Active, non-invasive, alternating current transcutaneous stimulation through electrodes placed transcranially on the mastoid regions. Treatment is self-administered, with participant control of device output level and duration according to perceived benefit. Minimum treatment duration is one-hour, with self-administered extension not to exceed 7 days.
Arm Title
NET sham
Arm Type
Sham Comparator
Arm Description
Sham, non-invasive, stimulation through electrodes placed transcranially on the mastoid regions. Treatment is self-administered, with participant control of device output level and duration according to perceived benefit. Minimum treatment duration is one-hour, with self-administered extension not to exceed 7 days.
Intervention Type
Device
Intervention Name(s)
NET
Intervention Description
NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
Primary Outcome Measure Information:
Title
Clinically meaningful decrease in opioid withdrawal symptom severity
Description
15% or greater reduction in total score on the Clinical Opiate Withdrawal Scale (COWS); scores range from 0 to 48, with higher scores indicating more severe withdrawal
Time Frame
from baseline to 1-hour of device stimulation
Secondary Outcome Measure Information:
Title
Comparison of decrease in opioid withdrawal symptom severity between active and sham device treatment
Description
Difference in the magnitude of reduction in total score on the Clinical Opiate Withdrawal Scale (COWS) between active and sham groups; scores range from 0 to 48, with higher scores indicating more severe withdrawal
Time Frame
from baseline to 1-hour of device stimulation
Title
Comparison of illicit opioid abstinence and no medications for treating opioid use disorder
Description
Difference between active and sham groups in the number of outpatient follow-up weeks with no illicit opioid use and no use of medications for treating opioid use disorder (based on weekly timeline followback interview and oral fluid drug tests)
Time Frame
Overall weekly number across 12 outpatient weeks
Title
Rate of adverse events
Description
All adverse events including dermal rash, inflammation, or other adverse events from use of the device
Time Frame
Number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Requiring detoxification from alcohol or benzodiazepines.
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.
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 extended-release buprenorphine (Sublocade) within 300 days of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark K Greenwald, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isaiah House Treatment Center
City
Willisburg
State/Province
Kentucky
ZIP/Postal Code
40078
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a proprietary device and company-sponsored clinical trial. No IPD will be made available.
Citations:
PubMed Identifier
36303593
Citation
Greenwald MK, Ghosh S, Winston JR. A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence. Contemp Clin Trials Commun. 2022 Oct 18;30:101018. doi: 10.1016/j.conctc.2022.101018. eCollection 2022 Dec.
Results Reference
derived
Learn more about this trial
NET Device for Treating Opioid Use Disorder
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