Low Intensity Focused Ultrasound in Cocaine Use Disorder
NCT07928648, Phase 1, Not yet recruiting, University of Pennsylvania
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Low Intensity Focused Ultrasound in Cocaine Use Disorder | ClinicalTrials.gov |
| NCT number | NCT07928648 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Pennsylvania | ClinicalTrials.gov |
| Conditions | Cocaine Use Disorder (CUD) | ClinicalTrials.gov |
| Interventions | Low Intensity Focused Ultrasound | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events by Severity | 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). | ClinicalTrials.gov |
| Primary | Number of Participants With Serious Adverse Events | 3 weeks | Number of participants in each arm with at least one serious adverse event. | ClinicalTrials.gov |
| Primary | Percentage of Participants Who Complete the Full Sonication Session | 1 day | Percentage of randomized participants in each arm who receive the complete planned bilateral sonication (or sham) session. | ClinicalTrials.gov |
| Primary | Percentage of Randomized Participants Who Complete All Study Visits | 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. | ClinicalTrials.gov |
| Primary | Percentage of Scheduled Daily CCQ-Brief Assessments Completed | 1 week | Number of Cocaine Craving Questionnaire-Brief assessments completed, divided by the number scheduled, per participant, summarized by arm. | ClinicalTrials.gov |
| Primary | Change From Baseline in Cue-Reactive BOLD Signal in Craving-Related Brain Regions on fMRI at Day 4 | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Food Cue Reactivity Task | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)