Clinical trial NCT06518785: Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
Official title: Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Substance Abuse Disorder
Alcohol
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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 exclusion criteria.

Primary outcomes:
measure: Incidence of LIFU-related adverse events.
timeFrame: Through study completion, an average of 5 weeks
measure: Reward network activity in response to alcohol cues.
timeFrame: 3 visits over 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Khaled Moussawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Legon 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.
citation: Stern 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.
citation: Mahoney 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.
citation: Martin 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.