Alcohol Use Disorder
Conditions
Keywords
Substance Use Disorder, Low-Intensity Focused Ultrasound, Transcranial Focused Ultrasound, Neuromodulation
Brief summary
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).
Interventions
An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Due to the objectives of the study, the identity of LIFU treatments will not be known to research staff performing the data analysis or participants.
Intervention model description
This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 18 years of age. 2. 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. 3. Be willing to undergo a brain MRI and follow study protocol.
Exclusion criteria
1. Pregnant or breastfeeding. 2. Presence of a condition or abnormality that would compromise the safety of the patient or the quality of the data. 3. Non-English speaking. 4. Other investigational AUD treatments. 5. Primary psychosis, Bipolar I, or severe personality disorder. 6. Active suicidality or history of suicide attempt in the past 5 years. 7. Cognitive impairment (MoCA \<24) 8. Significant medical or neurological disease, or life expectancy \<12 mos. 9. Significant brain abnormality on brain imaging. 10. Any MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of LIFU-related adverse events. | 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. | 3 visits over 3 weeks | Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI. |
Countries
United States
Contacts
CONTACTCatherine Borror, BS, CCRP
CONTACTSierra Brandts, BS
PRINCIPAL_INVESTIGATORKhaled Moussawi, MD, PhD
University of California, San Francisco
Outcome results
None listed