Low Intensity Focused Ultrasound in Cocaine Use Disorder

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

20 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Age 18-65 years
• Meets DSM-5 criteria for moderate or severe cocaine use disorder
• At least $100 worth of cocaine use in the past 30 days
• Able to provide written informed consent in English
• Able to comply with the study visit schedule and telehealth follow-ups
• Willing to attend the Day 3 overnight CRU admission
• Meets Penn safety criteria for research MRI (no contraindicated implants, no severe claustrophobia)

Exclusion Criteria:

• Meets DSM-5 criteria for moderate or severe substance use disorder for any substance other than cocaine, alcohol, marijuana, or nicotine
• Current diagnosis of a psychotic disorder, or another psychiatric disorder that, in the opinion of the PI, will interfere with completion of the study or place the participant at heightened risk through participation
• Active suicidal ideation with intent and plan, as defined by a score of five on the Columbia Suicide Severity Rating Scale (C-SSRS)
• History of epileptic seizures, with the exception of isolated febrile seizures in childhood
• History of significant head injury with loss of consciousness \> 3 minutes, or associated with skull fracture or intracranial bleeding, or abnormal MRI
• Cognitive impairment (MoCA \< 24) at screening
• Structural brain abnormality on baseline MRI (as determined by radiologist review)
• Skull anatomy or scalp characteristics that preclude safe LIFU delivery (as determined by individualized acoustic modeling)
• Pregnancy (positive urine pregnancy test) or breastfeeding
• Current use of medications known to substantially interact with the CNS effects being studied (e.g., benzodiazepines, opioid substitution therapy)
• Contraindication to MRI (metal implant, pacemaker, severe claustrophobia)
• Investigator judgment that participation would not be in the participant's best interest

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of Pennsylvania

Study start

Nov 1, 2026 Estimated

Primary completion

Aug 31, 2028 Estimated

Study completion

Sep 15, 2028 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts