LIFU for Treatment for Refractory Opioid Use Disorder

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Ali Rezai
Study ID
NCT06218706
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Intensity Focussed Ultrasound — DEVICE
    The major objective of this study is to further test safety, tolerability, and feasibility of LIFU in this population as well as investigate the impact of LIFU on opioid and other substance use. The primary endpoint is 90 days (Post-LIFU Week 12) following Active/Sham LIFU. After the primary endpoint is reached, the blind will be broken and the group who received Sham LIFU will cross-over and receive Active LIFU

Study Details

This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.

Key Dates

Start date
May 9, 2024
Status verified
Feb 2026
Primary completion
Oct 30, 2026
Completion
Mar 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: LIFU Treatment
  • Sham Comparator: Sham treatment

Primary Outcome Measure

Occurrence of Treatment Emergent Adverse Events [ Time Frame: Post-ExAblate Procedure through 90 day Follow-Up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WVU Rockefeller Neuroscience InstituteMorgantownWest Virginia26505
James Mahoney, PhD

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WVU Rockefeller Neuroscience Institute· Morgantown, WV

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