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This study aims to understand the role of Low-Intensity Focused Ultrasound on craving levels for cocaine as evidenced by diagnostic imaging of the dorsal anterior insula (dAI) and subjective ratings. Data analysis will serve to show if 1) LIFU is safe and effective and to 2) examine the effects of LIFU on dAI BOLD activity and craving in response to cocaine cue-exposure. The study will screen 60 individuals with Cocaine Use Disorder (CUD) to arrive at 30 enrolled subjects, based on a 2:1 screen/randomization ratio.
This is a randomized single-blind, active, sham-controlled study.
This study will enroll thirty (30) individuals, aged 18 years and older, that meet the criteria for CUD. Participants will be recruited from the general population and will be asked to complete cognitive testing and measures, self-reported craving measures, and diagnostic exams including magnetic resonance imaging (MRI) and Computed Tomography (CT). Participants will also undergo functional MRI which entails being shown cocaine-related photos at regular intervals.
All participants will receive LIFU and sham interventions, but will be randomized to one of two sessions, and will return one month after the second session for an in-person follow-up. In total, there are five (5) in-person visits and two (2) phone calls to assess for adverse events, conducted over eight (8) weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU) | Experimental | All subjects to receive LIFU and Sham in a randomized order. |
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| Sham LIFU | Sham Comparator | All subjects to receive LIFU and Sham in a randomized order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Intensity Focused Ultrasound | Device | Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure | Evidence on MRI of BOLD activity in the dAI region | 8 weeks |
| Decrease in average craving score by 25% for LIFU compared to sham | Participant, subjective rating of cocaine-related craving | 8 weeks |
| Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks. | Immediately after each LIFU or sham session, participants underwent a LIFU adverse event checklist, MoCAâ„¢, and focused neurological examination. Participants also completed a 24-hour follow-up safety assessment and a 4-week post-Visit 2 repeat assessment. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Please contact PI or Study Coordinator for more details.
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| Name | Affiliation | Role |
|---|---|---|
| Nassima Ait-Daoud Tiouririne, MD | University of Virginia, Center for Leading Edge Addiction Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Center for Leading Edge Addiction Research | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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At each of two intervention visits, participants will receive either LIFU or sham. At the completion of both visits, all participants will have received both, LIFU and sham.
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Single-blind study
| Sham LIFU device | Device | Sham LIFU device administered in one of two sessions |
|