Cocaine Use DisorderNCT05857852
Low-Intensity Focused Ultrasound for Cocaine Use Disorder
A study testing Low-Intensity Focused Ultrasound in people with Cocaine Use Disorder and Cocaine Dependence, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse
- What is being tested?
- Low-Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 years and older with a history of cocaine use disorder
- Have a current (past 6 months) DSM-5 diagnosis of cocaine use disorder (4 or more symptoms) assessed using the MINI neuropsychiatric interview
- Have a blood alcohol content by breathalyzer, equal to 0.000 when informed consent document is signed
- Ability to abstain from cocaine use at key points during study
- Willingness and ability to comply with scheduled visits and study procedures
- Ability to lie down for extended periods of time for imaging tests
Show all 9Show fewer
- Will have reliable transportation throughout study
- Will have a stable residence during the 2 weeks prior to randomization and not be at risk of losing housing in next 2 months
- Must meet criteria to have magnetic resonance imaging (MRI)
Who cannot join
- Please contact PI or Study Coordinator for more details.
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Center for Leading Edge Addiction Research
Charlottesville, Virginia, 22903
About this study
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.
Read the 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
- Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse, Ultrasound
- Being tested
- Low-Intensity Focused Ultrasound, Sham LIFU device
- Keywords
- Substance Use Disorders, Chemically-Induced Disorders, Substance-related disorders, Cocaine Addiction, Cocaine
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused UltrasoundDevice
Low-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions
Sham LIFU deviceDevice
Sham LIFU device administered in one of two sessions
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU) | Experimental | All subjects to receive LIFU and Sham in a randomized order. Receives: Device: Low-Intensity Focused Ultrasound |
| Sham LIFU | Sham comparator | All subjects to receive LIFU and Sham in a randomized order. Receives: Device: Sham LIFU device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Decrease in average craving score by 25% for LIFU compared to sham
Participant, subjective rating of cocaine-related craving
Measured: 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, MoCA™, and focused neurological examination. Participants also completed a 24-hour follow-up safety assessment and a 4-week post-Visit 2 repeat assessment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start24 Mar 2023
- Primary completion1 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud Tiouririne, MD, Principal investigator, University of Virginia, Center for Leading Edge Addiction Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857852
- Sponsor's protocol ID
- HSR220247
- Status last verified
- May 2026
- First submitted
- 4 May 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Intensity Focused Ultrasound for Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT05857852
- Acronym / sponsor ID
- HSR220247
- Conditions
- Cocaine Use Disorder, Cocaine Dependence, Cocaine Abuse, Ultrasound
- Keywords
- Substance Use Disorders, Chemically-Induced Disorders, Substance-related disorders, Cocaine Addiction, Cocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU) | Experimental | Device: Low-Intensity Focused UltrasoundAll subjects to receive LIFU and Sham in a randomized order. |
| Sham LIFU | Sham comparator | Device: Sham LIFU deviceAll subjects to receive LIFU and Sham in a randomized order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18 years and older with a history of cocaine use disorder
- Have a current (past 6 months) DSM-5 diagnosis of cocaine use disorder (4 or more symptoms) assessed using the MINI neuropsychiatric interview
- Have a blood alcohol content by breathalyzer, equal to 0.000 when informed consent document is signed
- Ability to abstain from cocaine use at key points during study
- Willingness and ability to comply with scheduled visits and study procedures
Key exclusion criteria (1 listed)
- Please contact PI or Study Coordinator for more details.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Focused UltrasoundLow-Intensity Focused Ultrasound administration to right dorsal anterior insula, in one of two sessions | Device | Low-Intensity Focused Ultrasound (LIFU) |
| Sham LIFU deviceSham LIFU device administered in one of two sessions | Device | Sham LIFU |
Primary outcome
Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure
Time frame: 8 weeks
Evidence on MRI of BOLD activity in the dAI region
Decrease in average craving score by 25% for LIFU compared to sham
Time frame: 8 weeks
Participant, subjective rating of cocaine-related craving
Number of subjects showing evidence of neurological or other adverse events related to LIFU at end of 8 weeks.
Time frame: 8 weeks
Immediately after each LIFU or sham session, participants underwent a LIFU adverse event checklist, MoCA™, and focused neurological examination. Participants also completed a 24-hour follow-up safety assessment and a 4-week post-Visit 2 repeat assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nassima Ait-Daoud Tiouririne, MD principal investigator
University of Virginia, Center for Leading Edge Addiction Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Focused Ultrasound in people with Cocaine Use Disorder and Cocaine Dependence, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.