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Low Intensity Focused Ultrasound for Cocaine Addiction

(LIFU-CUD Trial)

RS
GR
Overseen ByGiovanna Rocchio
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 1 study will test whether Low-Intensity Focused Ultrasound (LIFU), a non-invasive form of brain stimulation, is safe and feasible to deliver to the ventral striatum in adults with Cocaine Use Disorder (CUD), and whether it produces measurable changes in brain activity. Twenty participants will be enrolled at the University of Pennsylvania. This study is apart of the HEAL Initiative (https://www.nih.gov/heal) This study does not test whether LIFU can reduce cocaine use; it is designed only to evaluate the safety, feasibility, and neural effects of the intervention.

Who Is on the Research Team?

KS

Katherine Scangos, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with cocaine addiction who are interested in participating in a study testing a new brain stimulation technique. Specific inclusion and exclusion criteria will apply, but details are not provided here.

Inclusion Criteria

Meets Penn safety criteria for research MRI (no contraindicated implants, no severe claustrophobia)
Able to comply with the study visit schedule and telehealth follow-ups
I am willing to stay overnight at the clinic on Day 3.
See 4 more

Exclusion Criteria

Current diagnosis of a psychotic disorder or another psychiatric disorder that will interfere with study completion or increase risk
Active suicidal ideation with intent and plan, defined by a score of five on the Columbia Suicide Severity Rating Scale (C-SSRS)
Meets DSM-5 criteria for moderate or severe substance use disorder for any substance other than cocaine, alcohol, marijuana, or nicotine
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What Are the Treatments Tested in This Trial?

Interventions

  • Low Intensity Focused Ultrasound

Trial Overview

The study is testing the safety and practicality of Low Intensity Focused Ultrasound (LIFU), a non-invasive brain stimulation method targeting the ventral striatum, in people with cocaine use disorder. It does not test if LIFU reduces drug use.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active LIFUActive Control1 Intervention
Group II: Sham LIFUPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

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