Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Low Intensity Focused Ultrasound
DeviceAn inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: VS LIFU/ VPL LIFUExperimental treatment 1 intervention
Group B: VPL LIFU/VS LIFUActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of LIFU-related adverse events.
This will be assessed through monitoring for adverse events (AE) throughout the study.
Time frame
Through study completion, an average of 5 weeks2
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.
Time frame
3 visits over 3 weeksSponsors and contacts
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Source ClinicalTrials.gov