New York, NYNCT04197921Now EnrollingIRB Ready

Opioid-use Disorder Clinical Trial in New York, NY

Access cutting-edge opioid-use disorder treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by InSightec

Quick Self-Assessment

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Expert Care in New York

Access opioid-use disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related opioid-use disorder treatment provided free

Apply for This New York Location

Check if you qualify for this opioid-use disorder clinical trial in New York, NY

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Opioid-use Disorder Study in New York

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.

Sponsor: InSightec

Who Can Participate

Inclusion Criteria

Males and non-pregnant females, age 18 - 60 years old
Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via the SCID-5) of at least two years duration
Subject is 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; residential or inpatient treatment from the WVU Center for Hope and Healing or an affiliated WVU hospital; or receiving outpatient/inpatient/residential treatment from similar programs that are well known to the research team. If the subject is prescribed medication for AUD or OUD (e.g. buprenorphine-naloxone, naltrexone), they will be on a stable dose of the medication for the 7 days prior to the procedure. Stable is defined as within the therapeutic range but does not require same exact dose for 7 days.
Subject has been off opioids and other illicit substances, except for cannabis, confirmed via urine toxicology screen
The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)
Subject is able to communicate sensations during the Exablate Transcranial procedure
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
Subject is able to make own medical decisions as determined by the clinical team
Subject has signed and received a copy of the approved informed consent form

Exclusion Criteria

Subjects who are taking medications which may adversely interact with MOUD (See Appendix B for full list). Being on one of these medications would not automatically exclude a participant from study participation, does not automatically exclude a prospective subject from study participation. If a prospective or current subject is taking any medication listed in Appendix B, the study investigator is responsible for determining whether the subject is eligible for inclusion or continued study participation."
Subject with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
Subject with known intolerance or allergies to the MRI contrast agent gadolinium (GADOVIST®)
Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
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
Subject with implanted objects in the skull or the brain
Subject diagnosed with advanced kidney disease or on dialysis
Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
Subject with known unstable cardiac status or severe hypertension including:
Documented myocardial infarction within six months of enrollment
Unstable angina on medication
Unstable or worsening congestive heart failure
Left ventricular ejection fraction below the lower limit of normal
History of a hemodynamically unstable cardiac arrhythmia
Cardiac pacemaker
Severe hypertension (diastolic BP \> 100 on medication)
Subject with history of abnormal bleeding, hemorrhage, or coagulopathy
Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
Abnormal coagulation profile (PLT \< 100,000/ÎĽl), PT (\>13.9 sec) or PTT (\>37.5 sec), and INR \> 1.2. If values are outside the range of normal limits, any clinically significant value may be excluded as determined by a study investigator.
Subject with cerebrovascular disease as determined by MRI according to the Fazekas criteria. Grades II and III on the Fazekas scale should be excluded
Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5)
Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline
History of suicide attempt
Parental history of completed suicide
Subject meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD)
Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB)
Subject with brain tumors
Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area
Any known CNS infection or infection with the Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV). A diagnosis of Hepatitis C (HCV) alone is not exclusionary as long as hepatic function laboratory values are deemed not clinically significant by a study investigator and are ≤ 1.5 times the upper limit of normal.
Subject who has had deep brain stimulation or a prior stereotactic ablation of the NAc, basal ganglia or thalamus
Subject who has been administered botulinum toxins into the arm, neck, or face for 5 months prior to baseline
Subject who is currently participating in another clinical investigation with an active treatment arm
Subject unwilling to abstain from illicit substance use during the course of the study
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
Subject is non-English speaking
Subject is pregnant or planning to be pregnant

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04197921) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Opioid-use Disorder Treatment Options in New York, NY

If you're searching for opioid-use disorder treatment options in New York, NY, this clinical trial (NCT04197921) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced opioid-use disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all opioid-use disorder clinical trials near you to find additional studies recruiting in your area.

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