| Eligibility |
Inclusion Criteria:
1. Males and non-pregnant females, age 18 - 60 years old
2. Subject meets DSM-5 criteria for OUD and/or other SUDs including alcohol (assessed via
the SCID-5) of at least two years duration
3. 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.
4. Subject has been off opioids and other illicit substances, except for cannabis,
confirmed via urine toxicology screen
5. 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)
6. Subject is able to communicate sensations during the Exablate Transcranial procedure
7. Subject is willing to cooperate with the study requirements including compliance with
the regimen and completion of all study visits
8. Subject is able to make own medical decisions as determined by the clinical team
9. Subject has signed and received a copy of the approved informed consent form
Exclusion Criteria:
1. 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."
2. Subject with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices
3. Subject with known intolerance or allergies to the MRI contrast agent gadolinium
(GADOVIST®)
4. Subject who are unable or unwilling to tolerate the required prolonged stationary
position during treatment (approximately 2-3 hours)
5. 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
6. Subject with implanted objects in the skull or the brain
7. Subject diagnosed with advanced kidney disease or on dialysis
8. Subject with impaired renal function with estimated glomerular filtration rate <30
mL/min/1.73m2
9. Subject with known unstable cardiac status or severe hypertension including:
1. Documented myocardial infarction within six months of enrollment
2. Unstable angina on medication
3. Unstable or worsening congestive heart failure
4. Left ventricular ejection fraction below the lower limit of normal
5. History of a hemodynamically unstable cardiac arrhythmia
6. Cardiac pacemaker
7. Severe hypertension (diastolic BP > 100 on medication)
10. Subject with history of abnormal bleeding, hemorrhage, or coagulopathy
11. 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
12. Abnormal coagulation profile (PLT < 100,000/µl), 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.
13. Subject with cerebrovascular disease as determined by MRI according to the Fazekas
criteria. Grades II and III on the Fazekas scale should be excluded
14. 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)
15. 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
16. History of suicide attempt
17. Parental history of completed suicide
18. Subject meet the criteria for Cluster A or B Personality Disorders (assessed via
SCID-5-PD)
19. Diagnosis of dementia or any other disorder which has led to a clinically significant
cognitive impairment (assessed via NIHTB-CB)
20. Subject with brain tumors
21. Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis,
or other causes of reduced pulmonary vascular cross-sectional area
22. 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.
23. Subject who has had deep brain stimulation or a prior stereotactic ablation of the
NAc, basal ganglia or thalamus
24. Subject who has been administered botulinum toxins into the arm, neck, or face for 5
months prior to baseline
25. Subject who is currently participating in another clinical investigation with an
active treatment arm
26. Subject unwilling to abstain from illicit substance use during the course of the study
27. 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
28. Subject is non-English speaking
29. Subject is pregnant or planning to be pregnant
|
