Low Intensity Focused Ultrasound in Cocaine Use Disorder
Cocaine Use Disorder (CUD)
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 20 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Active LIFU
Participants in this arm will receive low intensity focused ultrasound
Device: Low Intensity Focused Ultrasound
Sham LIFU
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
Low Intensity Focused Ultrasound DEVICE
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Participants With Adverse Events by Severity
Plazo: 3 weeks
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).
Number of Participants With Serious Adverse Events
Plazo: 3 weeks
Number of participants in each arm with at least one serious adverse event.
Percentage of Participants Who Complete the Full Sonication Session
Plazo: 1 day
Percentage of randomized participants in each arm who receive the complete planned bilateral sonication (or sham) session.
Percentage of Randomized Participants Who Complete All Study Visits
Plazo: 3 weeks
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.
Percentage of Scheduled Daily CCQ-Brief Assessments Completed
Plazo: 1 week
Number of Cocaine Craving Questionnaire-Brief assessments completed, divided by the number scheduled, per participant, summarized by arm.
Change From Baseline in Cue-Reactive BOLD Signal in Craving-Related Brain Regions on fMRI at Day 4
Plazo: 1 week
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- University of Pennsylvania
- Inicio del estudio
- 1 nov 2026 Estimado
- Finalización primaria
- 31 ago 2028 Estimado
- Finalización del estudio
- 15 sept 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation of the Ventral Striatum in Cocaine Use Disorder
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026