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New treatment option for Opioid Use Disorder
Official title LIFU for Treatment for Refractory Opioid Use Disorder
ClinicalTrials.gov ID: NCT06218706
What this study is testing
- What it's testing
- This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 60
You may be able to join if
- 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...
- Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.
You likely can't join if
- Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses...
- History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically...
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.