Trials / Unknown
UnknownNCT05857852
Low-Intensity Focused Ultrasound for Cocaine Use Disorder
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Low-Intensity Focused Ultrasound | Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions |
| DEVICE | Sham LIFU device | Sham LIFU device administered in one of two sessions |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
- First posted
- 2023-05-15
- Last updated
- 2023-05-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05857852. Inclusion in this directory is not an endorsement.