LIFU Neuromodulation for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: InSightec
Must not be taking: Anticoagulants, Antiplatelets, Avastin
Disqualifiers: Schizophrenia, Bipolar, Severe hypertension, others
Stay on Your Current Meds
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other Substance Use Disorders (SUDs) by assessing its safety and tolerability in subjects with OUD.
Do I need to stop my current medications for the trial?
The trial does not specify that you must stop taking your current medications. However, if you are on medications that might interact with the treatment, the study investigator will decide if you can participate. If you are on medication for opioid or alcohol use disorder, you need to be on a stable dose for at least 7 days before the procedure.
What data supports the effectiveness of the treatment Exablate Model 4000 Type 2.0/2.1, Exablate Model 4000 Type 2.0/2.1, Exablate Neuro for opioid use disorder?
Research on noninvasive brain stimulation (NIBS) shows preliminary effectiveness for substance use disorders, suggesting that similar neuromodulation techniques might help with opioid use disorder. While specific data on the Exablate device for opioid use is limited, the general concept of brain stimulation has shown promise in related areas.
12345How is LIFU Neuromodulation treatment different from other treatments for opioid use disorder?
LIFU Neuromodulation is unique because it uses noninvasive brain stimulation to potentially help treat opioid use disorder, unlike traditional treatments that often rely on medications or psychotherapy. This approach targets the brain directly, which may offer a new way to reduce cravings and prevent relapse without the use of drugs.
13567Eligibility Criteria
This trial is for right-handed males and females aged 18-60 with Opioid Use Disorder who are part of the WVU Comprehensive Opioid Addiction Treatment Program, have been abstinent for 90 days, and on stable medication. Excluded are those with severe health issues, other clinical trials participation, non-English speakers, pregnancy or planning to be pregnant, certain medication use, inability to stay still for treatment duration, bleeding disorders or mental health conditions.Inclusion Criteria
I am willing to follow the study's requirements and attend all visits.
Subject has signed and received a copy of the approved informed consent form
Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
+4 more
Exclusion Criteria
You have objects implanted in your skull or brain.
My kidney function is not normal.
I have severe high blood pressure or unstable heart conditions.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Subjects undergo both sham and active ExAblate treatments with enhanced intensity
4 weeks
Multiple visits for treatment sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Regular follow-up visits
Participant Groups
The study tests Low Intensity Focused Ultrasound (LIFU) using the Exablate Model 4000 Type 2.0/2.1 as an additional treatment method for OUD by evaluating its safety and how well subjects can tolerate it.
1Treatment groups
Experimental Treatment
Group I: Sham/Active ExAblate Treatment Stage 1 and 2Experimental Treatment1 Intervention
Subject will undergo both Treatment 1 (sham) and Treatment 2 (with enhanced intensity). Subjects are blinded to the order of the sham vs active treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
Weill Cornell MedicineNew York, NY
West Virginia University: Rockefeller Neuroscience InstituteMorgantown, VA
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Who Is Running the Clinical Trial?
InSightecLead Sponsor
References
A Systematic Review of Noninvasive Brain Stimulation for Opioid Use Disorder. [2022]There is a great public health need to identify novel treatment strategies for opioid use disorder (OUD) in order to reduce relapse and overdose. Noninvasive brain stimulation (NIBS) has demonstrated preliminary effectiveness for substance use, but little is known about its use in OUD. Neuromodulation may represent a potential adjunctive treatment modality for OUD, so we conducted a systematic review to understand the state of the current research in this field.
Neural correlates of adherence to extended-release naltrexone pharmacotherapy in heroin dependence. [2021]Injectable extended-release naltrexone (XRNTX) presents an effective therapeutic strategy for opioid addiction, however its utility could be hampered by poor adherence. To gain a better insight into this phenomenon, we utilized blood oxygenation level-dependent functional magnetic resonance imaging (fMRI) in conjunction with a validated cue-induced craving procedure to examine neural correlates of XRNTX adherence. We operationalized treatment adherence as the number of monthly XRNTX injections (range: 0-3) administered to a group of fully detoxified heroin-dependent subjects (n=32). Additional outcomes included urine toxicology screening and self-reported tobacco use. The presented heroin-related visual cues reliably elicited heroin craving in all tested subjects. Nine, five, three and 15 of the participants, respectively, received zero, one, two and three XRNTX injections, predicted by the individual baseline fMRI signal change in response to the cues in the medial prefrontal cortex, a brain region involved in inhibitory self-control and emotional appraisal. The incidence of opioid-positive urines during the XRNTX therapy was low and remained about half the pre-treatment rate after the XRNTX ended. During the treatment, cigarette smoking behaviors followed patterns of opioid use, while cocaine consumption was increased with reductions in opioid use. The present data support the hypothesis that medial prefrontal cortex functions are involved in adherence to opioid antagonist therapy. A potential role of concurrent non-opioid addictive substances consumption during the XRNTX pharmacotherapy warrants further investigation. Our findings set the stage for further bio-behavioral investigations of the mechanisms of relapse prevention in opioid dependence.
A randomized, sham-controlled, quintuple-blinded trial to evaluate the NET device as an alternative to medication for promoting opioid abstinence. [2022]There is an unmet need for non-medication approaches to illicit opioid discontinuation and relapse prevention. The NET (NeuroElectric Therapy) Device is a non-invasive, battery-operated, portable, re-useable device designed to deliver bilateral transcranial transcutaneous alternating current electrical stimulation, and is intended to treat opioid use disorder (OUD) without medication. The device is a CE-marked Class IIa, non-significant risk, investigational medical device.
Opioid use and dropout from extended-release naltrexone in a controlled trial: implications for mechanism. [2022]Extended-release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post-hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo-controlled trial of extended-release injection naltrexone (XR-NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness.
A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham. [2022]Opioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).
Neuromodulation and Opioid Use Disorder: Ethical Opportunities for Canada. [2023]Despite increased efforts of government and non-government organisations to intervene via harm reduction and education initiatives, the opioid crisis has continued to worsen and has been exacerbated by the COVID-19 pandemic. In British Columbia, Canada, opioid overdose deaths in 2021 are the highest ever recorded. Neuromodulation procedures such as deep brain stimulation and repetitive transcranial magnetic stimulation have gained traction as treatments for opioid use disorder in various countries such as Germany, the Netherlands, the United States and China. However, these treatment options have been met with apprehension from both clinicians and patients, likely owing to fear, stigma and reluctance to label addiction as a brain disorder. Further complicating this landscape are socio-demographic factors, as marginalised communities are disproportionately burdened by addiction, while having poor access to care and a history of distrust in the health system. This multifactorial challenge involving many sociocultural factors requires culturally sensitive, interdisciplinary approaches to ensure direct-to-brain innovations are implemented ethically and equitably. This review summarises the state of the science for using neuromodulation to treat opioid use disorder, as well as the available ethical discourse surrounding the expansion of clinical trials and eventual widespread clinical implementation. Additional ethics discussions highlight opportunities for the engineering and clinical evolution of neuromodulation for opioid use disorder trials.
Percutaneous Auricular Nerve Stimulation (Neuromodulation) for Analgesia and Opioid-Sparing Following Knee and Hip Arthroplasty: A Proof-of-Concept Case Series. [2023]We present a case series to demonstrate proof-of-concept for the off-label use of an auricular neuromodulation device-originally developed to treat symptoms associated with opioid withdrawal-to instead provide analgesia and opioid-sparing following knee and hip arthroplasties. Within the recovery room, an auricular neuromodulation device (near-field stimulator system 2 [NSS-2] Bridge, Masimo) was applied to 5 patients. Average daily pain at rest and while moving was a median of 0 to 2 as measured on the 0 to 10 numeric rating scale, while median daily oxycodone use was 0 to 2.5 mg until device removal at home on postoperative day 5. One patient avoided opioid use entirely.