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Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness

30 lipca 2026 zaktualizowane przez: National Taiwan University Hospital

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Tajwan
      • Taipei, Tajwan, 100229
        • Rekrutacyjny
        • National Taiwan University Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 <60 bpm), abnormal systolic blood pressure (>180 mmHg or <90 mmHg), or abnormal diastolic blood pressure (>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 (<0.4), intracranial implants, or energy-absorbing structures or sensitive tissues along the ultrasound beam path that cannot be avoided (such as prior ventriculoperitoneal shunt sites, surgical metal clips, significant calcifications, extensive scarring, or any rigid implants). During the pre-treatment evaluation, a head CT scan will be performed to determine whether the skull density ratio is suitable for focused ultrasound treatment. Based on prior theoretical evidence, an excessively low skull density ratio may reduce the efficiency of MR-guided focused ultrasound and increase the risk of adverse effects, and therefore such participants are considered unsuitable for focused ultrasound treatment.
  • Structural abnormality of either side of the nucleus accumbens;
  • Contraindications to MRI, such as claustrophobia, allergy to MRI contrast agents, or the presence of metallic implants incompatible with MRI;
  • Contraindications to PET imaging, such as allergy to radiopharmaceutical contrast agents;
  • Inability to comply with trial-related instructions, lack of legal/behavioral capacity, or lack of motivation to receive treatment;
  • Pregnancy or breastfeeding;
  • Scalp atrophy or poor wound healing of the scalp;
  • Any other condition that, in the physician's judgment, makes the participant unsuitable for enrollment in the clinical trial.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Grupa eksperymentalna
Urządzenie: Low-intensity focused ultrasound
transcranially deliver focal energy into the accumbens nucleus in the brain
Pozorny komparator: Grupa kontrolna
Urządzenie: false stimulus
false stimulus

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Substance craving intensity
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Urinalysis
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Whether urine screening tests are positive for opioids and amphetamines. The intervention will be considered effective if the positivity rate decreases by 50% one month after the intervention compared with the time of intervention.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
Severity of Dependence
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Stimulant Relapse Risk
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mental health state
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Patient Health Questionnaire (PHQ-9) to measure participants' mental health state, greater scores of these scales shows worse mental health state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Executive function assessment
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Behavior Rating Inventory of Executive Function (BRIEF) to assess how well executive function of participants is.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Neuropsychological function assessment
Ramy czasowe: Before intervention, three months, six months, a year, two year after treatment
Using Cambridge Gambling Task (CGT) to assess Neuropsychological function since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Before intervention, three months, six months, a year, two year after treatment
functional Magnetic Resonance Imaging
Ramy czasowe: Before intervention, 24hours, a month, three months after treatment
Because the nucleus accumbens, the intervention target, may be involved in craving, functional magnetic resonance imaging (fMRI) will be used to assess changes in brain activation during the craving task before and after treatment.
Before intervention, 24hours, a month, three months after treatment
Positron Emission Tomography
Ramy czasowe: Before intervention, a month after treatment
Because neuromodulation may affect metabolic activity in the nucleus accumbens, positron emission tomography (PET) will be used to measure cerebral metabolism and compare changes before and after the intervention.
Before intervention, a month after treatment
Anxiety state
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Hamilton Anxiety Rating Scale (HAM-A), and Generalized Anxiety Disorder questionnaire(GAD-7) to measure participants' anxiety state, greater scores of these scales shows worse anxiety state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Depression state
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Hamilton Depression Rating Scale (HAM-D), to measure participants' mental health state, greater scores of these scales shows worse depression state.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Attendtion state
Ramy czasowe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Using Adult ADHD Self-Report Scale (ASRS) to assess how well attention state of participants is.
Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
Working memory capacity
Ramy czasowe: Before intervention, three months, six months, a year, two year after treatment
Using N-back test to assess working memory capacity since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
Before intervention, three months, six months, a year, two year after treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

National Taiwan University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 stycznia 2025

Zakończenie podstawowe (Szacowany)

31 grudnia 2030

Ukończenie studiów (Szacowany)

31 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

12 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 lipca 2026

Pierwszy wysłany (Rzeczywisty)

29 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

31 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 202404026DINC

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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