Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
2026年7月30日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Chien Yi-Ling
- 電話番号：#266013 +886 2-2312-3456
- メール：ntuh.peers@gmail.com
研究場所
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Taipei、台湾、100229
- 募集
- National Taiwan University Hospital
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コンタクト：
- Chien Yi-Ling
- 電話番号：#266013 +886 2-2312-3456
- メール：ntuh.peers@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：実験グループ
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transcranially deliver focal energy into the accumbens nucleus in the brain
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偽コンパレータ：対照群
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false stimulus
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Substance craving intensity
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using visual analogue scale (VAS) to measure craving intensity, higher score shows greater craving for substance
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Urinalysis
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
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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.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment
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Severity of Dependence
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Severity of Dependence Scale (SDS) to measure craving intensity, higher score shows greater severity of Dependence
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Stimulant Relapse Risk
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Stimulant Relapse Risk Scale (SRRS) to measure craving intensity, higher score shows higher stimulant relapse risk
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mental health state
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Patient Health Questionnaire (PHQ-9) to measure participants' mental health state, greater scores of these scales shows worse mental health state.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Executive function assessment
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Behavior Rating Inventory of Executive Function (BRIEF) to assess how well executive function of participants is.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Neuropsychological function assessment
時間枠：Before intervention, three months, six months, a year, two year after treatment
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Using Cambridge Gambling Task (CGT) to assess Neuropsychological function since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
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Before intervention, three months, six months, a year, two year after treatment
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functional Magnetic Resonance Imaging
時間枠：Before intervention, 24hours, a month, three months after treatment
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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.
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Before intervention, 24hours, a month, three months after treatment
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Positron Emission Tomography
時間枠：Before intervention, a month after treatment
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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.
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Before intervention, a month after treatment
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Anxiety state
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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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.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Depression state
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Hamilton Depression Rating Scale (HAM-D), to measure participants' mental health state, greater scores of these scales shows worse depression state.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Attendtion state
時間枠：Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Using Adult ADHD Self-Report Scale (ASRS) to assess how well attention state of participants is.
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Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment
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Working memory capacity
時間枠：Before intervention, three months, six months, a year, two year after treatment
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Using N-back test to assess working memory capacity since the intervention is to nucleus accumbens and could potentially affect Neuropsychological function.
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Before intervention, three months, six months, a year, two year after treatment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年1月1日
一次修了 (推定)
2030年12月31日
研究の完了 (推定)
2030年12月31日
試験登録日
最初に提出
2026年3月12日
QC基準を満たした最初の提出物
2026年7月27日
最初の投稿 (実際)
2026年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月31日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7月1日
詳しくは
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