What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder (OUD) include medications such as methadone, buprenorphine, and naltrexone. Methadone can cause side effects like constipation, nausea, vomiting, sedation, and respiratory depression. Buprenorphine may lead to headaches, insomnia, mood changes, and potential respiratory depression when combined with other central nervous system depressants. Naltrexone implants, used to block opioid effects, can cause injection site reactions, liver enzyme abnormalities, and in rare cases, precipitated withdrawal. Non-pharmacological treatments like the NET Device, which uses neuromodulation, aim to reduce cravings and withdrawal symptoms without these medication-related side effects, though specific side effects of the NET Device itself are not detailed in the provided context.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder, including methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that help reduce cravings and withdrawal symptoms, while naltrexone is an opioid antagonist that blocks the effects of opioids. Buprenorphine is available in various forms, including sublingual tablets and implants. While the NET Device focuses on neuromodulation, which is a different approach, it is important to note that neuromodulation techniques are still under investigation and have not yet received FDA approval for OUD treatment.

What other types of research exist?

Promising novel alternatives to the NET Device for Opioid Use Disorder patients include: 1) Buprenorphine-naloxone buccal soluble film, which offers a novel delivery method for established medication-assisted treatment. 2) Long-acting sustained-release naltrexone implants, which provide extended protection against relapse. 3) Gabapentin, which has shown efficacy in reducing cannabis use and may have potential for OUD. 4) Nabiximols, a cannabis-based medication, which is being explored for its potential benefits in managing withdrawal symptoms and cravings.

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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)

Summary

This trial tests a device that sends small electrical currents through the skin on the head to help people with opioid addiction who want to quit without other medications. It aims to see if this device can reduce withdrawal symptoms and help maintain abstinence from opioids.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and number of adverse events during inpatient device use (which can range across participants from 1 hour to 7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinically meaningful decrease in opioid withdrawal symptom severity

Secondary study objectives

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

~350

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opioid Use Disorder (OUD) include pharmacological and neuromodulation approaches. Pharmacological treatments like methadone, buprenorphine, and naltrexone target opioid receptors in the brain to reduce cravings and withdrawal symptoms. Methadone and buprenorphine are opioid agonists that activate opioid receptors to a lesser degree than illicit opioids, reducing withdrawal symptoms and cravings without producing the same high. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids. Neuromodulation treatments, such as the NET Device, aim to reduce opioid cravings and withdrawal symptoms by modulating neural activity through electrical or magnetic stimulation. Understanding these mechanisms is crucial for OUD patients as it helps tailor treatment plans to individual needs, potentially improving adherence and outcomes.