RecruitingNot Applicable

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

Taiwan60 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 diso…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Substance craving intensity

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment

Urinalysis

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment

Severity of Dependence

Timeframe: 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

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment

Trial details

NCT IDNCT07734623

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Chien Yi-Ling

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

View on ClinicalTrials.gov More Opioid Use Disorder, Severe trials

Plain-language summary

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Substance craving intensity

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment

Urinalysis

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year after treatment

Severity of Dependence

Timeframe: 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

Timeframe: Before intervention, one week, a month, three months, six months, nine months, a year, one and half year and two years after treatment