Deep Brain Stimulation for Alcohol Use Disorder

NCT05522751 | Completed Results DMC FDA Device

• 1 other identifier: STUDY22030036
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the limbic pallidum in participants with severe alcohol use disorder (AUD) who have advanced but compensated liver fibrosis.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• Number of Serious Adverse Events (Safety and Tolerability)

  This will be evaluated based on number and seriousness of adverse events associated with DBS implantation and stimulation (e.g., infection, bleeding, cognitive or behavioral side effects).

  4-52 weeks

• Recruitment (Feasibility)

  This will be evaluated based on number of participants recruited and enrolled in the study between study start date and primary completion date.

  0-71 weeks

• Proportion of Completed Assessments (Feasibility)

  This will be evaluated based on the average percentage of evaluations completed across participants during the study duration out of total required assessments to measure the participants' adherence to the study protocol.

  4-52 weeks

Secondary Outcomes (4)

• Overall Functioning

  6 months

• Alcohol Use - Percent Days Abstinent

  6 months

• Alcohol Use - Drinks Per Drinking Day

  6 months

• Target Engagement

  6 months

Other Outcomes (1)

• Cue Reactivity Craving Score

  6 months

Study Arms (1)

AUD DBS

EXPERIMENTAL

This is a single arm study. Participants will undergo baseline medical and psychiatric assessments, cognitive and behavioral testing, and positron emission tomography (PET) imaging. One to two weeks later, participants will undergo neurosurgical implantation of DBS electrodes in the limbic pallidum and a neurostimulator. Four weeks after DBS system implantation, the DBS system will be turned ON and the stimulation parameters optimized. Participants will be followed biweekly then monthly for repeat comprehensive assessments.

Device: DBS

Interventions

DBS DEVICE

Bilateral DBS electrodes will be implanted into the limbic pallidum of participants with severe alcohol use disorder and advanced but compensated liver disease.

AUD DBS

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (all genders) 21 to 75 years old.
• Severe primary Alcohol Use Disorder (AUD) (\>= 6 Diagnostic and Statistical Manual-5 AUD criteria) with or without other substance use disorders.
• Participants are seeking treatment for their AUD (participants receiving medications or other therapy for AUD are eligible).
• Participants have insight into their alcohol use disorder (score \>26 on the recognition subscale of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES V.8)).
• Participant has advanced compensated alcohol-associated liver disease (ALD). Compensated is defined as asymptomatic per clinical evaluation (by hepatologist or internist). Advanced is defined as fibrosis stage \>= 3; if not previously diagnosed, fibrosis stage \>= 3 will be diagnosed with liver elastography using a liver stiffness cutoff \>=15kiloPascal
• AUD is treatment refractory: unable to achieve sustained remission (\>12 months) over the past 5 years, despite treatment attempts, with at least one treatment attempt involving completed residential or outpatient treatment program with pharmacotherapy, behavioral therapy, or both.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Social support system and stable living arrangement to provide assurances that the subject will adhere to study requirements: family or friends who live with or near the subject, and can provide collateral information, monitor the subject's behavior, support, and encourage the subject to participate in follow-up visits and evaluations. This is evaluated by a neuropsychologist.
• For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to DBS surgery and agreement to use such a method during study participation, and after study completion if they elect to keep the DBS system implanted and ON.

You may not qualify if:

• Pregnancy or lactation.
• Non-English speaking.
• AUD treatment with another investigational drug or other intervention within 3 months.
• History of primary psychosis or Bipolar I disorder per the psychiatric evaluation or Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 measure.
• History of severe personality disorder that could interfere with study participation (e.g., antisocial personality disorder) per the psychiatric evaluation, neuropsychological evaluation, or Structured Clinical Interview for the Diagnostic and Statistical Manual-5 measure.
• Intelligence quotient \<75 as measured by Wechesler Abbreviated Scale of Intelligence (evaluated by a neuropsychologist).
• History of suicidal attempts in the past 5 years or current suicidal thoughts per psychiatric evaluation and Columbia-Suicide Severity Rating Scale (C-SSRS).
• Decompensated ALD: clinically obvious ascites, hepatic encephalopathy, jaundice episodes, large esophageal varices with or without variceal bleeding, hepatorenal syndrome, per the clinical evaluation (by hepatologist or internist).
• Coagulopathy: international normalized ratio (INR) \> 1.4, activated partial thromboplastin time (aPTT) \> 40 s, platelets \< 100,000.
• Current clinically significant medical or neurologic disease that affects brain function (e.g., recent stroke, myocardial infarction, seizures not due to alcohol withdrawal).
• Clinically significant abnormality on structural brain MRI scan.
• Life expectancy less than 18 months per the clinical judgement during medical evaluation (e.g., no terminal cancers).
• Any labeled DBS contraindication or inability to have brain MRI: certain pacemakers, metal in body, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery, infection, and coagulopathy.

Sponsors & Collaborators

• Khaled Moussawi: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Recruitment was halted after the SAE occurrence in one subject. Only one subject completed the study protocol.

Results Point of Contact

• Title: Khaled Moussawi
• Organization: University of California San Francisco

khaled.moussawi@ucsf.edu

415-502-6343

Study Officials

• Khaled Moussawi, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Neurology, and Bioengineering

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 31, 2022
• Study Start: January 10, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after study completion.
• Access Criteria: all data and information must be de-identified.

Locations

US (1)