Neuromodulation for Substance Use Disorder

Overseen By Tina Bland

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Manish Ranjan

Disqualifiers: Neurological disorder, Stroke, Schizophrenia, Suicide attempt, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NaviFus Model101, which uses focused ultrasound (FUS) to assist individuals with substance use disorders, such as opioid addiction. The main goal is to determine if this treatment is safe and feasible for these conditions. Suitable participants have experienced opioid or other substance use disorders for at least two years and are currently receiving outpatient treatment. The trial will examine how the treatment impacts brain areas associated with addiction. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in addiction treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study staff or your healthcare provider.

What prior data suggests that the NaviFus Model101 is safe for neuromodulation in substance use disorder?

A previous study demonstrated promising safety results for the NaviFus Model101 treatment. Research indicates that the focused ultrasound (FUS) method, applied to specific brain areas, was well-tolerated by participants. Reports confirmed that this treatment did not cause any serious side effects. Participants generally handled it well, making it a feasible option for those with opioid use disorder (OUD) and other substance use disorders (SUDs). Overall, current findings suggest the treatment appears safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NaviFus Model101 because it offers a new approach to treating substance use disorder through LIFU (Low-Intensity Focused Ultrasound) neuromodulation. Unlike traditional treatments that often involve medication or behavioral therapy, this method targets the brain's neural circuits directly, potentially offering a non-invasive alternative. By focusing on the NAc/VC regions of the brain, it aims to modulate the areas associated with addiction, possibly leading to more effective and faster results without the side effects associated with medication.

What evidence suggests that this neuromodulation technique is effective for substance use disorder?

Research has shown that using low-intensity focused ultrasound (LIFU) on the nucleus accumbens could be a promising treatment for substance use disorders (SUDs). In this trial, participants will undergo LIFU neuromodulation using the NaviFus Model101 device. This method, known as neuromodulation, is safe and can help reduce drug cravings and use, particularly in individuals with severe opioid addiction. Studies have found that LIFU can accurately alter brain activity, which might aid in managing addiction. Early results suggest it could be a new tool for treating SUDs. While more research is needed, its ability to target specific brain areas makes it a strong option for those struggling with substance use. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 22-60 with substance use disorders (SUDs), including opioid use disorder (OUD). Participants must be in outpatient treatment, under the care of a mental health or addiction specialist, and have at least a two-year history of SUD. They need to communicate openly with their healthcare providers about the trial.

Inclusion Criteria

I have been diagnosed with a substance use disorder for at least 2 years.

I am currently getting outpatient care for opioid addiction at WVU.

I am between 22 and 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo FUS neuromodulation targeting the NAc/VC with behavioral and substance craving assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

5 visits (in-person) on Day 1, Week 1, 4, 8, and 12

What Are the Treatments Tested in This Trial?

Interventions

• NaviFus Model101

Trial Overview The study is testing the safety and feasibility of using NaviFus Model101 for neuromodulation therapy on individuals with OUD or other SUDs. Neuromodulation involves altering nerve activity to potentially reduce cravings or withdrawal symptoms associated with substance abuse.

How Is the Trial Designed?

Group I: LIFU Neuromodulation Experimental Treatment 1 Intervention

Participants will undergo FUS in the bilateral NAc/VC

Who Is Running the Clinical Trial?

Manish Ranjan

Lead Sponsor

Ali Rezai

Lead Sponsor

Trials

6

Recruited

90+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07010016

Neuromodulation in Substance Use Disorders It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10540197/

Low-intensity focused ultrasound targeting the nucleus ... Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial

3. patlynk.com patlynk.com/trial/NCT07010016

Focused Ultrasound Neuromodulation for Substance Use ... This study explores a new technique called Focused Ultrasound (FUS) to help people who have problems with opioid use or other substances.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612502/

The therapeutic potential of low-intensity focused ultrasound ... LIFU is a promising modality for precise and invasive modulation of brain activity, capable of redefining the landscape of SUD treatment.

5. sciencedirect.com sciencedirect.com/science/article/pii/S000632232500023X

Exploring a Novel Treatment for Severe Opioid Use Disorder Conclusions. NAc FUS neuromodulation is safe and a potential adjunctive treatment for reducing drug cravings and use in individuals with severe ...

6. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-for-opioid-addiction-new-clinical-trial-results-published/

Focused Ultrasound for Opioid Addiction: New Clinical ... Positive Results Initial results showed the bilateral NAc LIFU neuromodulation to be safe, well-tolerated, and feasible for this treatment group ...