Trial Outcomes & Findings for NET Device for Treating Opioid Use Disorder (NCT NCT04916600)
NCT ID: NCT04916600
Last Updated: 2025-09-18
Results Overview
percentage of participants with 15% or greater reduction (from baseline to 1 hour device utilization) in total score on the Clinical Opiate Withdrawal Scale (COWS); scores range from 0 to 48, with higher scores indicating more severe withdrawal
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
from baseline to 1-hour of device stimulation
Results posted on
2025-09-18
Participant Flow
A total of 108 participants were enrolled. 53 were enrolled in the active device arm and 55 were enrolled in the sham device arm.
Randomization to active vs. sham conditions was preserved.
Participant milestones
| Measure |
NET Active
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.
|
NET Sham
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.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
|
Overall Study
COMPLETED
|
53
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NET Device for Treating Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
NET Active
n=53 Participants
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.
|
NET Sham
n=55 Participants
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.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
34.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to 1-hour of device stimulationPopulation: All enrolled participants who completed 1 hour of randomly assigned intervention (active or sham)
percentage of participants with 15% or greater reduction (from baseline to 1 hour device utilization) in total score on the Clinical Opiate Withdrawal Scale (COWS); scores range from 0 to 48, with higher scores indicating more severe withdrawal
Outcome measures
| Measure |
NET Active
n=53 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=55 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Clinically Meaningful Decrease in Opioid Withdrawal Symptom Severity
|
98.1 percentage of participants
|
83.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from baseline to 1-hour of device stimulationPopulation: All enrolled participants who completed 1 hour of randomly assigned device utilization (active or sham)
Difference in percentage change 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
Outcome measures
| Measure |
NET Active
n=53 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=55 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Comparison of Change in Opioid Withdrawal Symptom Severity Between Active and Sham Device Treatment
|
-61.7 percentage change in COWS score
Standard Deviation 4.9
|
-45.8 percentage change in COWS score
Standard Deviation 8.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Overall percentage of zero use-days (no illicit opioids without medications for treating opioid use disorder) during post-discharge weeks 1-12Population: All participants who (during the inpatient period) received randomly assigned device exposure (active or sham)
Percentage of participants with no illicit opioid use without use of medications for treating opioid use disorder (based on weekly post-discharge timeline followback interview). This outcome definition is a conjunction (i.e. required combination) of a participant not using any illicit opioid AND not using any medication for treating opioid use disorder at each assessment time point. This is consistent with the intent of the study to examine the efficacy of the device as a monotherapy (without relying on medications).
Outcome measures
| Measure |
NET Active
n=23 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=25 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
n=21 Participants
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
n=34 Participants
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Comparison of the Rate of Illicit Opioid Abstinence Without Medications for Treating Opioid Use Disorder
|
87.0 percentage of participants
|
40.0 percentage of participants
|
52.4 percentage of participants
|
52.9 percentage of participants
|
SECONDARY outcome
Timeframe: Number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days)Population: All participants receiving exposure to the randomly assigned intervention (active or sham)
All adverse events including dermal rash, inflammation, or other adverse events from use of the device
Outcome measures
| Measure |
NET Active
n=53 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=55 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Rate of Adverse Events
|
1 Participants
|
0 Participants
|
—
|
—
|
POST_HOC outcome
Timeframe: Days 1 to 30 post-dischargePercentage of participants with zero days of using illicit opioids, illicit psychostimulants, and medications for treating opioid use disorder (MOUD)
Outcome measures
| Measure |
NET Active
n=23 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=80 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Zero Days Use
|
87.0 percentage of participants
|
65.0 percentage of participants
|
—
|
—
|
POST_HOC outcome
Timeframe: Days 1 to 30 post-dischargeAverage number of days using illicit opioids, illicit psychostimulants, or medications for opioid use disorder (MOUD)
Outcome measures
| Measure |
NET Active
n=23 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=80 Participants
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
Sham Device >= 24 Hours
Those randomly assigned to sham device who self-administered stimulation \>=24 hours
|
Sham Device <24 Hours Utilization
Those randomly assigned to sham device who self-administered stimulation \<24 hours
|
|---|---|---|---|---|
|
Average Number of Use-days
|
0.5 days
Standard Deviation 1.9
|
3.9 days
Standard Deviation 7.6
|
—
|
—
|
Adverse Events
NET Active
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NET Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NET Active
n=53 participants at risk
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
NET Sham
n=55 participants at risk
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.
NET: NET is an investigational device that received CE-Mark in April 2009 as a Class IIa active medical device
|
|---|---|---|
|
Nervous system disorders
Headache
|
1.9%
1/53 • Number of events 1 • Daily from the time of initiating device use (inpatient day 1) throughout the remaining inpatient period (up to 28 days), and continuing weekly from post-discharge week 1 throughout the end of the post-discharge period (end of week 12).
AEs were queried systematically throughout the inpatient period and weekly during the post-discharge period.
|
0.00%
0/55 • Daily from the time of initiating device use (inpatient day 1) throughout the remaining inpatient period (up to 28 days), and continuing weekly from post-discharge week 1 throughout the end of the post-discharge period (end of week 12).
AEs were queried systematically throughout the inpatient period and weekly during the post-discharge period.
|
Additional Information
Dr. Mark Greenwald, Professor
Wayne State University School of Medicine
Phone: 3139933965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60