Alcohol Use DisorderNCT05522751
Deep Brain Stimulation for Alcohol Use Disorder
A study testing DBS in people with Alcohol Use Disorder, run by Khaled Moussawi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Limbic Pallidum Deep Brain Stimulation for the Treatment of Severe Alcohol Use Disorder
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.
Read the detailed description
Participants with severe AUD 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 repeated comprehensive assessments.
- Conditions
- Alcohol Use Disorder
- Being tested
- DBS
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
Bilateral DBS electrodes will be implanted into the limbic pallidum of participants with severe alcohol use disorder and advanced but compensated liver disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 4-52 weeks
Secondary outcomes (4)
Overall Functioning
Overall function and disability will be measured using standardized questionnaire World Health Organization Disability Assessment 2.0 (WHODAS2.0) score before and after DBS activation (raw score 0-180, higher is worse). The focus of analysis was limited to the 6-month timepoint.
Measured: 6 months
Alcohol Use - Percent Days Abstinent
assessment of alcohol use will be measured through percent days abstinent (PDA) at baseline (pver preceding 6 months) and at 6 months after DBS activation. PDA at baseline is assessed over the preceding 180 days. PDA at 6 months post-DBS activation is assessed over the preceding 30 days.
Measured: 6 months
Alcohol Use - Drinks Per Drinking Day
assessment of alcohol use will be measured through drinks per drinking day (DDD) before and after DBS activation. The focus of analysis was limited to the 6-month timepoint. DDD at baseline is assessed over the preceding 180 days. DDD at 6 months post-DBS activation is assessed over the preceding 30 days.
Measured: 6 months
Target Engagement
This will be assessed by measuring the percent change in brain metabolism with 18fluoro-Deoxy-Glucose (FDG) PET scans before and after DBS activation. The timepoint 4 weeks post-surgery was excluded because breath alcohol test was positive on that day.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start10 Jan 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khaled Moussawi
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Khaled Moussawi, University of Pittsburgh
- Investigators
- Khaled Moussawi, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522751
- Sponsor's protocol ID
- STUDY22030036
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2022
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant data could be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limbic Pallidum Deep Brain Stimulation for the Treatment of Severe Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05522751
- Acronym / sponsor ID
- STUDY22030036
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Khaled MoussawiUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants with severe AUD 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 repeated comprehensive assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUD DBS | Experimental | Device: DBSThis 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBSBilateral DBS electrodes will be implanted into the limbic pallidum of participants with severe alcohol use disorder and advanced but compensated liver disease. | Device | AUD DBS |
Primary outcome
Number of Serious Adverse Events (Safety and Tolerability)
Time frame: 4-52 weeks
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).
Recruitment (Feasibility)
Time frame: 0-71 weeks
This will be evaluated based on number of participants recruited and enrolled in the study between study start date and primary completion date.
Proportion of Completed Assessments (Feasibility)
Time frame: 4-52 weeks
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 secondary outcomes
Overall Functioning
Time frame: 6 months
Alcohol Use - Percent Days Abstinent
Time frame: 6 months
Alcohol Use - Drinks Per Drinking Day
Time frame: 6 months
Target Engagement
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified participant data could be shared with other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Moussawi, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS in people with Alcohol Use Disorder, run by Khaled Moussawi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (Safety and Tolerability) (time frame: 4-52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.