Sound waves aim to quiet opioid cravings
NCT ID NCT06218706
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if low intensity focused ultrasound (LIFU) can help people with severe opioid addiction who haven't improved with other treatments. About 34 adults aged 22-60 will receive either real or sham ultrasound to specific brain areas. Researchers will monitor safety and measure changes in opioid use through urine tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 22 - 60 years at time of enrollment. * Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history. * Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception. Exclusion Criteria: * Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours. * History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator). * History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC). * Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS). * Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments. * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. * Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. * Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 * Hepatic function laboratory values which are \> 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator. * Past or present diagnosis of schizophrenia or psychotic disorder. * Subject unwilling to attempt abstinence from illicit substance use during the course of the study. * Unable to speak, read and understand English. * Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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WVU Rockefeller Neuroscience Institute
RECRUITINGMorgantown, West Virginia, 26505, United States
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