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Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

Ultrasound Neuromodulation of the Brain for Alcohol Use Disorder

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

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.

Study details
    Alcohol Use Disorder

NCT06518785

University of California, San Francisco

17 January 2025

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