Substance Use DisorderNCT07010016
Neuromodulation in Substance Use Disorders
A study testing NaviFus Model101 in people with Substance Use Disorder, run by Manish Ranjan at 1 site in United States.
Trial summary
The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- NaviFus Model101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 22 - 60 years at time of enrollment.
- Fulfill current DSM-5 diagnostic criteria for OUD and/or other SUDs with at least a 2-year history.
- Currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction
- Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; or receiving outpatient/inpatient/residential treatment from similar SUD treatment programs.
- Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
- Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
Who cannot join
- Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
- History of any clinically significant neurological disorder.
- History of stroke or brain lesion with observable structural abnormalities in the targeted brain region.
- Clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
- An abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings).
- More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
Show all 13Show fewer
- Past or present diagnosis of schizophrenia or psychotic disorder (assessed via SCID-
- History of medically verified suicide attempt within the past year.
- Meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD).
- Current substance use treatment mandated by court of law.
- Subject who is currently participating in another clinical investigation with an active
- treatment arm.
- Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
About this study
Official title: Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders
The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.
Read the detailed description
This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.
- Conditions
- Substance Use Disorder
- Being tested
- NaviFus Model101
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviFus Model101Device
FUS Neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| LIFU Neuromodulation | Other | Participants will undergo FUS in the bilateral NAc/VC Receives: Device: NaviFus Model101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events
Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs
Measured: Beginning Day 0 (the day of the FUS procedure) through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start7 Aug 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manish Ranjan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manish Ranjan, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010016
- Sponsor's protocol ID
- RNI_NMD_SUD
- Status last verified
- Oct 2025
- First submitted
- 21 May 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07010016
- Acronym / sponsor ID
- RNI_NMD_SUD
- Conditions
- Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Manish RanjanUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.
Detailed description
This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFU Neuromodulation | Other | Device: NaviFus Model101Participants will undergo FUS in the bilateral NAc/VC |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 22 - 60 years at time of enrollment.
- Fulfill current DSM-5 diagnostic criteria for OUD and/or other SUDs with at least a 2-year history.
- Currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction
- Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; or receiving outpatient/inpatient/residential treatment from similar SUD treatment programs.
- Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
Key exclusion criteria (13 listed)
- Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
- History of any clinically significant neurological disorder.
- History of stroke or brain lesion with observable structural abnormalities in the targeted brain region.
- Clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
- An abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviFus Model101FUS Neuromodulation | Device | LIFU Neuromodulation |
Primary outcome
Occurrence of Treatment Emergent Adverse Events
Time frame: Beginning Day 0 (the day of the FUS procedure) through Week 4
Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviFus Model101 in people with Substance Use Disorder, run by Manish Ranjan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (time frame: Beginning Day 0 (the day of the FUS procedure) through Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.