Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

Part of paid clinical trials in Tampa, Florida.

Sponsor
InSightec
Study ID
NCT04197921
Status
Recruiting
Apply to this trial

Conditions

  • Opioid-use Disorder
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Exablate Model 4000 Type 2.0/2.1 — DEVICE
    There are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.

Study Details

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.

Key Dates

Start date
Nov 27, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Sham/Active ExAblate Treatment Stage 1 and 2
    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.

Primary Outcome Measure

Occurrence of Treatment Emergent Adverse Events [ Time Frame: Post-ExAblate Procedure through 4 Month Follow-Up ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Carlos Rodriguez-Cosme
[email protected]
813-844-7564
Yarema Bezchlibnyk, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Maryland, BaltimoreBaltimoreMaryland21201
Katie Henry, MS
[email protected]
410-328-0939
Alexander Ksendzovsky, MD, PhD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Anna Angkatavanich
[email protected]
Michael Kaplitt, MD, PhD (PRINCIPAL_INVESTIGATOR)
West Virginia University: Rockefeller Neuroscience InstituteMorgantownWest Virginia26505
Jennifer Marton
[email protected]
304-293-5886
Ali Rezai, MD (PRINCIPAL_INVESTIGATOR)
Marc Haut, PhD (SUB_INVESTIGATOR)
James Mahoney, PhD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Tampa General Hospital· Tampa, FLUniversity of Maryland, Baltimore· Baltimore, MDWeill Cornell Medicine· New York, NYWest Virginia University: Rockefeller Neuroscience Institute· Morgantown, WV

Related Studies