Cocaine Use Disorder (CUD)NCT07852923
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults With Cocaine Use Disorder
A study testing tFUS in people with Cocaine Use Disorder (CUD), run by Mary Phillips, MD MD (Cantab) at 1 site in United States.
Trial summary
The investigators aim to examine the effect of transcranial focused ultrasound (tFUS) on brain activity and cocaine craving in adults with cocaine use disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine Use Disorder (CUD)
- What is being tested?
- tFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-45 years of age
- Uses cocaine as a primary drug at a minimum frequency of 1x/mo; any period of abstinence within the past month does not exceed 1 week
Who cannot join
- Not between 18-45 years of age
- Cocaine is not used as a primary drug, is used at a frequency of less than 1x/mo, and/or a period of abstinence lasting longer than 1 week has occurred within past month
- Present/lifetime history of primary psychosis or Bipolar Disorder (DSM-5 criteria, SCID-5, SCID-5-PD, YMRS>10), present suicidal ideation, or current depressive episode
- History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
- Family history of epilepsy
- Use of substances with seizure risk (e.g., stimulants), benzodiazepines, and dopaminergic psychotropic medications in the past month
Show all 15Show fewer
- Mini-Mental State Examination (MMSE) score (cognitive state) <24
- Premorbid NAART IQ estimate <85
- Visual disturbance: <20/40 Snellen visual acuity
- Left/mixed handedness (Annett criteria)
- Binge drinking (as defined by NIAA criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or >3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days (to avoid tFUS during alcohol withdrawal). Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed
- MRI exclusion criteria: e.g., surgical implants; claustrophobia; positive pregnancy test for females (performed at the MRRC)/self-report pregnancy
- Unable to understand English
- Any implanted neural device since it is not known whether tFUS would interfere with other implanted neural devices
- Color blind
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Research Coordinator, Phillips_Lab@upmc.edu
About this study
Official title: Modulating Ventral Striatal Activity and Connectivity With Transcranial Focused Ultrasound as a Putative Novel Intervention for Cocaine Use Disorder
The investigators aim to examine the effect of transcranial focused ultrasound (tFUS) on brain activity and cocaine craving in adults with cocaine use disorder.
- Conditions
- Cocaine Use Disorder (CUD)
- Being tested
- tFUS, Sham tFUS
- Keywords
- transcranial focused ultrasound, Magnetic Resonance Imaging, Reward
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tFUSDevice
tFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely.
Sham tFUSDevice
Sham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham
| Study group | Role | What they receive |
|---|---|---|
| VS tFUS/Sham tFUS | Experimental | VS tFUS (tFUS applied to the ventral striatum); Sham tFUS (go through the motions of applying tFUS to the VS) Receives: Device: tFUS; Device: Sham tFUS |
| Sham tFUS/VS tFUS | Experimental | Sham tFUS (go through the motions of applying tFUS to the VS); VS tFUS (tFUS applied to the ventral striatum) Receives: Device: tFUS; Device: Sham tFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS
Measure of Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS
Measured: Two visits over up to 8 weeks
Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS
Measure of Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS
Measured: Two visits over up to 8 weeks
Cocaine craving before receiving tFUS to the Ventral Striatum (VS)
The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.
Measured: Two visits over up to 8 weeks
Cocaine craving after receiving tFUS to the Ventral Striatum (VS)
The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.
Measured: Two visits over up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use Disorder (CUD)Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mary Phillips, MD MD (Cantab)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Mary Phillips, MD MD (Cantab), University of Pittsburgh
- Investigators
- Mary L Phillips, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852923
- Sponsor's protocol ID
- STUDY25060111
- Other IDs
- UH3DA060431
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data from this study will be available for access by the research community via National Institute of Mental Health Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Ventral Striatal Activity and Connectivity With Transcranial Focused Ultrasound as a Putative Novel Intervention for Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT07852923
- Acronym / sponsor ID
- STUDY25060111
- Conditions
- Cocaine Use Disorder (CUD)
- Keywords
- transcranial focused ultrasound, Magnetic Resonance Imaging, Reward
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Mary Phillips, MD MD (Cantab)University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 1 Oct 2026 (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.
The investigators aim to examine the effect of transcranial focused ultrasound (tFUS) on brain activity and cocaine craving in adults with cocaine use disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VS tFUS/Sham tFUS | Experimental | Device: tFUS, Device: Sham tFUSVS tFUS (tFUS applied to the ventral striatum); Sham tFUS (go through the motions of applying tFUS to the VS) |
| Sham tFUS/VS tFUS | Experimental | Device: tFUS, Device: Sham tFUSSham tFUS (go through the motions of applying tFUS to the VS); VS tFUS (tFUS applied to the ventral striatum) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18-45 years of age
- Uses cocaine as a primary drug at a minimum frequency of 1x/mo; any period of abstinence within the past month does not exceed 1 week
Key exclusion criteria (15 listed)
- Not between 18-45 years of age
- Cocaine is not used as a primary drug, is used at a frequency of less than 1x/mo, and/or a period of abstinence lasting longer than 1 week has occurred within past month
- Present/lifetime history of primary psychosis or Bipolar Disorder (DSM-5 criteria, SCID-5, SCID-5-PD, YMRS>10), present suicidal ideation, or current depressive episode
- History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
- Family history of epilepsy
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 |
|---|---|---|
| tFUStFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely. | Device | Sham tFUS/VS tFUS, VS tFUS/Sham tFUS |
| Sham tFUSSham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham | Device | Sham tFUS/VS tFUS, VS tFUS/Sham tFUS |
Primary outcome
Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS
Time frame: Two visits over up to 8 weeks
Measure of Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS
Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS
Time frame: Two visits over up to 8 weeks
Measure of Ventral striatum (VS) activity to cocaine cues after receiving tFUS to the VS
Cocaine craving before receiving tFUS to the Ventral Striatum (VS)
Time frame: Two visits over up to 8 weeks
The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.
Cocaine craving after receiving tFUS to the Ventral Striatum (VS)
Time frame: Two visits over up to 8 weeks
The Cocaine Craving Questionnaire-Now (CCQ-Now) is a 45-item self-report measure of current cocaine craving. Each item is rated on a 7-point Likert scale. A total score is calculated by summing all items (after reverse-scoring applicable items per the scoring manual), with possible scores ranging from 45 to 315. Higher total scores indicate greater current craving for cocaine, while lower scores indicate less craving. The questionnaire assesses multiple dimensions of craving, including desire to use cocaine, anticipation of positive effects, anticipation of relief from withdrawal or negative mood, intention or planning to use cocaine, and perceived control over cocaine use. Only the total CCQ-Now score will be analyzed and reported for this outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. Data from this study will be available for access by the research community via National Institute of Mental Health Data Archive (NDA).
Related trials for Cocaine Use Disorder (CUD)
RecruitingPhase 1/2
The Impact of Cobenfy Maintenance on Cocaine's Effects
Cocaine Use Disorder (CUD)
Recruiting
The Role of Potassium Channels in Working Memory Impairments of Chronic Cocaine Users
Cocaine Use Disorder (CUD), Cognitive Impairments
RecruitingEarly Phase 1
Imaging CRF X NOP Interactions in CUD
Cocaine Use Disorder
Recruiting
Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment of Cocaine Use Disorder
Cocaine Use Disorder (CUD)
Recruiting
Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder
Alcohol Use Disorder (AUD), Cocaine Use Disorder (CUD)
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.
Mary L Phillips principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tFUS in people with Cocaine Use Disorder (CUD), run by Mary Phillips, MD MD (Cantab) 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 2 inclusion and 15 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: opening soon, as of the sponsor's last update on 1 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventral striatum (VS) activity to cocaine cues before receiving tFUS to the VS (time frame: Two visits over up to 8 weeks). The study lists 4 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 1 Oct 2026.