Alcohol Use DisorderNCT06518785
Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
A study testing Low Intensity Focused Ultrasound in people with Alcohol Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Low Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Sep 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age.
- Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period.
- Be willing to undergo a brain MRI and follow study protocol.
Who cannot join
- Pregnant or breastfeeding.
- Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.
- Non-English speaking.
- Other investigational AUD treatments.
- Primary psychosis, Bipolar I, or severe personality disorder.
- Active suicidality or history of suicide attempt in the past 5 years.
Show all 10Show fewer
- Cognitive impairment (MoCA <24)
- Significant medical or neurological disease, or life expectancy <12 mos.
- Significant brain abnormality on brain imaging.
- Any MRI exclusion criteria.
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, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Catherine Borror, BS, CCRP, 415-514-6551, TN2Lab@ucsf.edu
Sierra Brandts, BS, 415-514-6551, TN2Lab@ucsf.edu
About this study
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
Read the detailed description
This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).
- Conditions
- Alcohol Use Disorder
- Being tested
- Low Intensity Focused Ultrasound
- Keywords
- Substance Use Disorder, Low-Intensity Focused Ultrasound, Transcranial Focused Ultrasound, Neuromodulation
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Focused UltrasoundDevice
Also called LIFU
An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.
| Study group | Role | What they receive |
|---|---|---|
| VS LIFU/ VPL LIFU | Experimental | Participants will be assigned to receive VS LIFU during the first LIFU treatment session. Receives: Device: Low Intensity Focused Ultrasound |
| VPL LIFU/VS LIFU | Active comparator | Participants will be assigned to receive VPL LIFU during the first LIFU treatment session. Receives: Device: Low Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of LIFU-related adverse events.
This will be assessed through monitoring for adverse events (AE) throughout the study.
Measured: Through study completion, an average of 5 weeks
Reward network activity in response to alcohol cues.
Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI.
Measured: 3 visits over 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start7 Jan 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled Moussawi, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518785
- Sponsor's protocol ID
- 24-41883
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sarica C, Nankoo JF, Fomenko A, Grippe TC, Yamamoto K, Samuel N, Milano V, Vetkas A, Darmani G, Cizmeci MN, Lozano AM, Chen R. Human Studies of Transcranial Ultrasound neuromodulation: A systematic review of effectiveness and safety. Brain Stimul. 2022 May-Jun;15(3):737-746. doi: 10.1016/j.brs.2022.05.002. Epub 2022 May 6.
PubMed 35533835Legon W, Adams S, Bansal P, Patel PD, Hobbs L, Ai L, Mueller JK, Meekins G, Gillick BT. A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Sci Rep. 2020 Mar 27;10(1):5573. doi: 10.1038/s41598-020-62265-8.
PubMed 32221350Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
PubMed 34198105Mahoney JJ, Haut MW, Carpenter J, Ranjan M, Thompson-Lake DGY, Marton JL, Zheng W, Berry JH, Tirumalai P, Mears A, D'Haese P, Finomore VS, Hodder SL, Rezai AR. Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial. Front Psychiatry. 2023 Sep 15;14:1211566. doi: 10.3389/fpsyt.2023.1211566. eCollection 2023.
PubMed 37779628Martin E, Aubry JF, Schafer M, Verhagen L, Treeby B, Pauly KB. ITRUSST consensus on standardised reporting for transcranial ultrasound stimulation. Brain Stimul. 2024 May-Jun;17(3):607-615. doi: 10.1016/j.brs.2024.04.013. Epub 2024 Apr 25.
PubMed 38670224
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06518785
- Acronym / sponsor ID
- 24-41883
- Conditions
- Alcohol Use Disorder
- Keywords
- Substance Use Disorder, Low-Intensity Focused Ultrasound, Transcranial Focused Ultrasound, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 24 Jul 2024 (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 examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
Detailed description
This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
| Arm | Type | Receives |
|---|---|---|
| VS LIFU/ VPL LIFU | Experimental | Device: Low Intensity Focused UltrasoundParticipants will be assigned to receive VS LIFU during the first LIFU treatment session. |
| VPL LIFU/VS LIFU | Active comparator | Device: Low Intensity Focused UltrasoundParticipants will be assigned to receive VPL LIFU during the first LIFU treatment session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age.
- Documentation of an AUD diagnosis per DSM-5 criteria as evidenced by problematic pattern of alcohol use leading to clinically significant impairment or distress, as manifested by at least two of the DSM-5 criteria, occurring within a 12-month period.
- Be willing to undergo a brain MRI and follow study protocol.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding.
- Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data.
- Non-English speaking.
- Other investigational AUD treatments.
- Primary psychosis, Bipolar I, or severe personality disorder.
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 UltrasoundAlso: LIFUAn inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used. | Device | VPL LIFU/VS LIFU, VS LIFU/ VPL LIFU |
Primary outcome
Incidence of LIFU-related adverse events.
Time frame: Through study completion, an average of 5 weeks
This will be assessed through monitoring for adverse events (AE) throughout the study.
Reward network activity in response to alcohol cues.
Time frame: 3 visits over 3 weeks
Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI.
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 11 Sep 2026.
- Background: PubMed 35533835Sarica C, Nankoo JF, Fomenko A, Grippe TC, Yamamoto K, Samuel N, Milano V, Vetkas A, Darmani G, Cizmeci MN, Lozano AM, Chen R. Human Studies of Transcranial Ultrasound neuromodulation: A systematic review of effectiveness and safety. Brain Stimul. 2022 May-Jun;15(3):737-746. doi: 10.1016/j.brs.2022.05.002. Epub 2022 May 6.
- Background: PubMed 32221350Legon W, Adams S, Bansal P, Patel PD, Hobbs L, Ai L, Mueller JK, Meekins G, Gillick BT. A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Sci Rep. 2020 Mar 27;10(1):5573. doi: 10.1038/s41598-020-62265-8.
- Background: PubMed 34198105Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
- Background: PubMed 37779628Mahoney JJ, Haut MW, Carpenter J, Ranjan M, Thompson-Lake DGY, Marton JL, Zheng W, Berry JH, Tirumalai P, Mears A, D'Haese P, Finomore VS, Hodder SL, Rezai AR. Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial. Front Psychiatry. 2023 Sep 15;14:1211566. doi: 10.3389/fpsyt.2023.1211566. eCollection 2023.
- Background: PubMed 38670224Martin E, Aubry JF, Schafer M, Verhagen L, Treeby B, Pauly KB. ITRUSST consensus on standardised reporting for transcranial ultrasound stimulation. Brain Stimul. 2024 May-Jun;17(3):607-615. doi: 10.1016/j.brs.2024.04.013. Epub 2024 Apr 25.
- 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.
Khaled Moussawi, MD, PhD principal investigator
University of California, San Francisco
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 Alcohol Use Disorder, run by University of California, San Francisco 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 Sep 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?
Contact Catherine Borror, BS, CCRP (415-514-6551, TN2Lab@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of LIFU-related adverse events. (time frame: Through study completion, an average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518785, which also lists 5 linked publications.
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 11 Sep 2026.