Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2030-09-30

Brief Summary

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This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.

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Detailed Description

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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

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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VS LIFU/ VPL LIFU

Participants will be assigned to receive VS LIFU during the first LIFU treatment session.

Group Type EXPERIMENTAL

Low Intensity Focused Ultrasound

Intervention Type DEVICE

An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.

VPL LIFU/VS LIFU

Participants will be assigned to receive VPL LIFU during the first LIFU treatment session.

Group Type ACTIVE_COMPARATOR

Low Intensity Focused Ultrasound

Intervention Type DEVICE

An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.

Interventions

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Low Intensity Focused Ultrasound

An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used.

Intervention Type DEVICE

Other Intervention Names

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LIFU

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No