NCT06518785 · University of California, San Francisco
Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
What this study is about
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
View original scientific description
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
Interventions
DEVICE
Low Intensity Focused Ultrasound
An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Cognitive impairment (MoCA \<24)
- Significant medical or neurological disease, or life expectancy \<12 mos.
- Significant brain abnormality on brain imaging.
- Any MRI exclusion criteria.
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2025 · Source of record for eligibility and locations