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NET for Opioid Use Disorder
N/A
Waitlist Available
Led By Mark K Greenwald, PhD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days)
Awards & highlights
Study Summary
This trial will compare the NET device to a sham device in treating persons with OUD who want to be abstinent from opioids without MOUD.
Who is the study for?
This trial is for adults aged 18-65 with Opioid Use Disorder who want to quit opioids without medication. They must be in good health, not have serious psychiatric conditions like psychosis or bipolar disorder, and women must use effective contraception. It's not for those on certain medications, pregnant or breastfeeding women, or people with pacemakers.Check my eligibility
What is being tested?
The NET Device is being tested to see if it helps people stop using opioids without the help of other medications. Participants are randomly assigned to either get the real device or a sham (fake) one while they try to become opioid-free.See study design
What are the potential side effects?
Since this summary does not provide specific side effects of the NET Device, we can assume that potential side effects might include discomfort at the site of application or placebo-like symptoms due to its nature as a non-medication intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically meaningful decrease in opioid withdrawal symptom severity
Secondary outcome measures
Comparison of decrease in opioid withdrawal symptom severity between active and sham device treatment
Comparison of illicit opioid abstinence and no medications for treating opioid use disorder
Rate of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NET activeExperimental Treatment1 Intervention
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.
Group II: NET shamPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NET
2009
N/A
~50
Find a Location
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,365 Total Patients Enrolled
NET Recovery CorpUNKNOWN
Isaiah HouseUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to stop drinking alcohol or taking benzodiazepines before participating in the study.You are experiencing severe symptoms of opiate withdrawal, as measured by the COWS score of 13 or higher.You have long-term conditions such as seizures or dementia, and are taking medication for them.You do not have any medical conditions that require you to take opioids regularly, other than opioid use disorder.You have a heart pacemaker.You do not want to use medication to help with opioid addiction.
Research Study Groups:
This trial has the following groups:- Group 1: NET sham
- Group 2: NET active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly citizens welcome to participate in this research?
"The age restriction for this study are patients that are 18 years old or older, and no older than 65."
Answered by AI
Are there any unfilled patient slots in this clinical trial?
"The listing for this clinical trial on clinicaltrials.gov shows that it is currently open for enrolment. This trial was originally posted on November 24th, 2021 and was most recently edited on December 24th, 2021."
Answered by AI
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