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NCT07734623
Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
Conditions: Opioid Use Disorder, Severe, Amphetamine Use Disorder
Sex: All
Ages: 20 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: National Taiwan University Hospital
Location: National Taiwan University Hospital Taipei
Summary
The goal of this clinical trial is to investigate the safety and efficacy of applying low-intensity focused ultrasound targeting the nucleus accumbens in individuals with opioid or amphetamine use disorders. The main questions it aims to answer is:
\- Low-intensity focused ultrasound targeting the nucleus accumbens demonstrates sufficient safety and predictable therapeutic efficacy in individuals with opioid or amphetamine use disorders.
Participants will:
* Received Low-intensity focused ultrasound neuromodulation once
* Visit the clinic for checkups and asessment at 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, 1.5 years, and 2 years after received Low-intensity focused ultrasound neuromodulation.
Eligibility Criteria
Inclusion Criteria:
* Meets the DSM-5 criteria for opioid use disorder or amphetamine use disorder, with a severity level of severe, and does not currently meet the criteria for in sustained remission;
* Within 7 days prior to the screening assessment, the participant must have been receiving a stable dose of medication treatment, such as methadone, buprenorphine/naloxone, or naltrexone;
* Within 7 days prior to the screening assessment, the participant must have abstained from illicit substances and alcohol, and must have a negative urine drug test;
* The bilateral nucleus accumbens must be clearly identifiable on magnetic resonance imaging (MRI), such that they are sufficient for treatment targeting and for indirect measurement from other anatomical structures;
* The participant must be able to communicate effectively and express their feelings and experiences during the study procedures;
* The participant must be willing to comply with the study requirements, including adherence to prescribed medications and cooperation with study visits and assessments.
(The participant must have the capacity to make independent medical decisions, as determined by the clinical team.)
Exclusion Criteria:
* Presence of neurological disorders or major psychiatric disorders, such as acute-phase schizophrenia spectrum disorder, acute-phase bipolar disorder, acute-phase major depressive disorder, severe cognitive impairment, or recent suicidal ideation or plan;
* Antisocial personality disorder;
* Occurrence of major physical health problems within 6 months prior to the trial, including: Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmia, tachycardia or bradycardia (\>100 bpm or \180 mmHg or \180 mmHg); Platelet or coagulation abnormalities (INR \> 1.5) or current use of medications that may cause anticoagulation, such as warfarin or Avastin; Renal dysfunction (eGFR \< 30 mL/min/1.73 m²) or ongoing hemodialysis; Severe infection; Immunocompromised status; History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within the past 6 months, or brain tumor; Neurological diseases, such as stroke, epilepsy, Parkinson's disease, dementia, or related disorders; Any other physical illness that, based on clinical evaluation, may pose a significant risk to physical function or life during treatment.
* Participants who, upon evaluation, are deemed unsuitable for MR-guided focused ultrasound treatment, including those with a low skull density ratio (\
Source: ClinicalTrials.gov (NCT07734623). StuddyBuddy aggregates publicly available trial information.