Actively Recruiting
Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2026-01-12
3
Participants Needed
1
Research Sites
412 weeks
Total Duration
On this page
Sponsors
A
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
CONDITIONS
Official Title
Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 22 years and older with opioid use disorder diagnosed using DSM-5 criteria with at least 5 years history
- Opioid use disorder must be the main disorder
- History of ongoing or past opioid use, relapse, or cravings despite trying or attending at least two different treatment programs such as methadone, buprenorphine, residential treatment, therapy, or similar
- Self-reported ongoing opioid cravings
- Completed neuropsychological evaluation approved by a neuropsychologist
- Completed psychiatric evaluation approved by a psychiatrist
- Brain MRI performed and reviewed by neurosurgeon with no contraindications for DBS
- Platelet count above 125,000 per cubic mm and normal blood clotting tests
- Negative blood cultures to rule out infection
You will not qualify if you...
- Prior brain surgery
- Hamilton Depression Rating Scale score greater than 17 or moderate suicide risk unless deemed appropriate by clinical judgment
- History of uncontrolled or ongoing seizures
- Suspected dementia or Mini Mental State Exam score less than 25
- Contraindications for MRI including implanted electrical or metal devices (excluding dental braces), claustrophobia, or weight over 180 kg (400 lb)
- Females who are pregnant or nursing; females of childbearing potential must have a negative pregnancy test and agree to use birth control during and 30 days after the trial
- Blood clotting disorders requiring anticoagulation or antiplatelet medication
- Diagnosed neurological disorders such as multiple sclerosis, Parkinson's disease, or stroke
- Severe brain atrophy or subdural fluid collections seen on MRI
- Evidence of endocarditis
- Primary language other than English
- Any other medical condition that makes participation unsuitable according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
N
Nestor Tomycz, MD
CONTACT
D
Donald Whiting, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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