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NCT04197921 · ClinicalTrials.gov registry record · NA

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

A NA study of Opioid Use Disorder and Substance Use Disorders, sponsored by InSightec.

Recruiting
Registry status
NA
Development phase
29
Enrollment target
4
Study locations

NCT04197921: Recruiting NA study of Opioid Use Disorder and Substance Use Disorders, sponsored by InSightec.

NCT04197921 is a NA study of Opioid Use Disorder and Substance Use Disorders that is actively recruiting participants, run by InSightec. The registered enrollment target is 29 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04197921, a NA study of Opioid Use Disorder and Substance Use Disorders, is actively recruiting participants, sponsored by InSightec.

RECRUITING
Registry status
NA
Development phase
29 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.

Primary Outcome

Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

Conditions Studied

Opioid Use Disorder Substance Use Disorders

Interventions

  • DEVICE Exablate Model 4000 Type 2.0/2.1

Study Locations (4)

Florida

  • Tampa General Hospital - Tampa

Maryland

  • University of Maryland, Baltimore - Baltimore

New York

  • Weill Cornell Medicine - New York

West Virginia

  • West Virginia University: Rockefeller Neuroscience Institute - Morgantown

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2019-11-27
Est. Completion 2027-12-31
Phase NA
InSightec

38 total trials

What NCT04197921 shows while recruiting

NCT04197921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Exablate Model 4000 Type 2.0/2.1 is the first listed.

NCT04197921 reports a single indexed study location in Florida, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT04197921 about?

NCT04197921 is a clinical study titled "Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)". The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in su...

What is the current status of trial NCT04197921?

This trial is currently recruiting. It is a NA study. The enrollment target is 29 participants. The study started on 2019-11-27. Estimated completion is 2027-12-31.

What conditions does trial NCT04197921 study?

This clinical trial studies the following conditions: Opioid Use Disorder, Substance Use Disorders.

What interventions are being tested in trial NCT04197921?

The interventions under investigation include: Exablate Model 4000 Type 2.0/2.1 (DEVICE).

Who is sponsoring clinical trial NCT04197921?

This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04197921 being conducted?

This trial has 4 study locations across Florida, Maryland, New York, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Opioid Use Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04197921's enrollment target sits among peer trials

29 213th of 257 higher than 44 of 257 other Opioid Use Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04197921

Source: ClinicalTrials.gov NCT04197921, the US trial registry maintained by the National Library of Medicine. NCT04197921 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.