A Phase 1 interventional study of Low Intensity Focused Ultrasound in Cocaine Use Disorder (CUD), sponsored by University of Pennsylvania. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Pennsylvania · Phase 1, Interventional, and Other
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.
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive low intensity focused ultrasound
Device: Low Intensity Focused Ultrasound
Participants in this arm will receive unfocused ultrasound, which will mimic the auditory and peripheral sensations of active stimulation without delivering meaningful pressure to the brain target
Device: Low Intensity Focused Ultrasound
This study utilizes a single-element ultrasound transducer (Sonic Concepts) positioned over the head of each participant. Transducer alignment with the target brain region is maintained throughout the session using a neuronavigation tracking system (BrainSight) referenced to reflective markers on the participant's head. Participants wear headphones playing white noise throughout the session, identical for both active and sham conditions, to mask any procedure-related auditory cues. LIFU (or sham) is applied to both sides of the brain targeting the same area of the brain (Ventral Striatum). The device has been determined by the study's regulatory reviewers to pose non-significant risk and is not FDA-approved for any indication; its use in this study is investigational.
Number of Participants With Adverse Events by Severity
Number of participants in each arm (active LIFU, sham) with at least one adverse event, assessed using the CTCAE grade (1-5) and by relationship to the study intervention (unrelated, unlikely, possibly, probably, or definitely related).
Time frame: 3 weeks
Number of Participants With Serious Adverse Events
Number of participants in each arm with at least one serious adverse event.
Time frame: 3 weeks
Percentage of Participants Who Complete the Full Sonication Session
Percentage of randomized participants in each arm who receive the complete planned bilateral sonication (or sham) session.
Time frame: 1 day
Percentage of Randomized Participants Who Complete All Study Visits
Percentage of randomized participants in each arm who complete every scheduled study visit, including the Day 4 post-sonication MRI and the Day 21 End-of-Study visit.
Time frame: 3 weeks
Percentage of Scheduled Daily CCQ-Brief Assessments Completed
Number of Cocaine Craving Questionnaire-Brief assessments completed, divided by the number scheduled, per participant, summarized by arm.
Time frame: 1 week
Change From Baseline in Cue-Reactive BOLD Signal in Craving-Related Brain Regions on fMRI at Day 4
Change in BOLD response to cocaine cues versus neutral cues during the cue-reactivity fMRI task, measured in four pre-specified regions: ventral striatum, dorsal anterior cingulate cortex, amygdala, and orbitofrontal cortex. Reported separately for each region and each arm.
Time frame: 1 week
Plan to share: No
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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