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Device

Deep Brain Stimulation for Alcohol Use Disorder

N/A
Waitlist Available
Led By Khaled Moussawi, MD, PhD
Research Sponsored by Khaled Moussawi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant with advanced compensated alcohol-associated liver disease (ALD) defined as asymptomatic per clinical evaluation (by hepatologist or internist) and fibrosis stage >= 3
Adults (all genders) 21 to 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 and 12 months post dbs.
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a brain stimulation treatment for people with severe alcohol use disorder and liver fibrosis.

Who is the study for?
This trial is for adults aged 21-75 with severe alcohol use disorder and advanced but compensated liver fibrosis. They must understand their condition, have tried treatments without success for over 5 years, and be willing to follow the study's procedures. Women of childbearing age must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Deep Brain Stimulation (DBS) on a part of the brain called the limbic pallidum in participants with severe alcoholism who haven't responded well to other treatments. It aims to assess if DBS is safe, tolerable, and feasible.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but generally may include discomfort at implant site, headache, nausea, changes in mood or behavior due to stimulation of brain areas during DBS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have advanced liver disease from alcohol use but don't show symptoms.
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I am between 21 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 and 12 months post dbs.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 months post dbs. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completed assessments (Feasibility)
Incidence of Adverse events (Safety and Tolerability)
Recruitment (Feasibility)
Secondary outcome measures
Alcohol Use Disorder
Alcohol use - percent days abstinent
Target engagement
+1 more
Other outcome measures
Cue reactivity
Impulsivity
Reward processing
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AUD DBSExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DBS
2011
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,509 Total Patients Enrolled
422 Trials studying Alcoholism
985,206 Patients Enrolled for Alcoholism
Khaled MoussawiLead Sponsor
Khaled Moussawi, MD, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

DBS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05522751 — N/A
Alcoholism Research Study Groups: AUD DBS

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol accommodating individuals of twenty years and above?

"According to the restrictions listed on the trial's eligibility criteria, potential participants must be over 21 and under 75 years of age."

Answered by AI

How many participants is the clinical trial accepting?

"Indeed, the information on clinicaltrials.gov confirms that this research trial is currently recruiting candidates. The study was initially posted to the site on January 10th 2023 and most recently updated on April 1st of the same year. Presently 3 participants are required from a single location."

Answered by AI

Are there currently any available slots for individuals to enroll in this clinical trial?

"Affirmative, the information on clinicaltrials.gov demonstrates that this study is currently seeking volunteers. It was originally listed on January 10th 2023 and updated on April 1st of the same year. Approximately 3 participants are necessary for recruitment from a single research site."

Answered by AI

What are the requirements for joining this medical experiment?

"This clinical trial is in search of 3 adult participants, aged between 21 and 75, afflicted with a severe Alcohol Use Disorder (AUD) (>= 6 Diagnostic and Statistical Manual-5 AUD criteria). Furthermore, these individuals must exhibit an understanding of their own condition (scoring >26 on the recognition subscale of SOCRATES V.8), show signs of advanced compensated liver damage due to alcohol consumption (as diagnosed by a hepatologist or internist via elastography at >=15kiloPascal stiffness cutoff), have unsuccessfully treated their AUD over the past 5 years despite treatment attempts including pharmacotherapy/behavioral therapy programs such as residential"

Answered by AI

What goals is this experiment striving to fulfill?

"Over the course of 4 to 52 weeks, this study's primary outcome will be an assessment of adverse events and their associated safety/tolerance. Secondary objectives include calculating percent days abstinent in order to gauge alcohol use, analysing overall functioning through WHODAS2.0 scores before and after activation, as well as measuring change in brain metabolism by utilizing 18fluoro-Deoxy-Glucose (FDG) PET scans pre and post DBS activations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Deep Brain Stimulation for Alcohol Use Disorder
Khaled Moussawi 2023. "Deep Brain Stimulation for Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05522751.
~0 spots leftby May 2024
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