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

NCT07734623 | Recruiting

• 1 other identifier: 202404026DINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder, Severe; Amphetamine Use Disorder

Outcome Measures

Primary Outcomes (4)

• Substance craving intensity

  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

  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

  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

  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

Secondary Outcomes (9)

• 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

  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

  Before intervention, three months, six months, a year, two year after treatment

• functional Magnetic Resonance Imaging

  Before intervention, 24hours, a month, three months after treatment

• Positron Emission Tomography

  Before intervention, a month after treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

Device: Low-intensity focused ultrasound

Control group

SHAM COMPARATOR

Device: false stimulus

Interventions

Low-intensity focused ultrasound DEVICE

transcranially deliver focal energy into the accumbens nucleus in the brain

Experimental group

false stimulus DEVICE

false stimulus

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100229, Taiwan

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Chien Yi-Ling

CONTACT

+886 2-2312-3456; ntuh.peers@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: July 29, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

TW (1)