Deep brain stimulation for opioid use disorder

Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder

This study is testing whether deep brain stimulation can help people who haven't had success with other treatments for opioid addiction by reducing cravings and relapses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT04354077 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety and efficacy of deep brain stimulation (DBS) targeting the nucleus accumbens in patients with treatment-refractory opioid use disorder. It will involve three participants who have not responded to standard addiction treatments and continue to experience relapses. The study will assess primary outcomes related to the safety of the procedure and secondary outcomes including relapse rates, opioid cravings, and overall health markers. Participants will undergo DBS implantation and subsequent programming to optimize treatment effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with a long history of opioid use disorder who have failed multiple treatment attempts.

Not a fit: Patients currently abusing illicit substances or those without a confirmed diagnosis of opioid use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce opioid use and relapse rates in patients with severe opioid use disorder.

How similar studies have performed: While deep brain stimulation has shown promise in other addiction contexts, this specific application for opioid use disorder is novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria

1. Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) with at least a 5-year history
2. OUD must be the primary disorder
3. History of ongoing or previous opioid use, relapse, and/or cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.
4. Self-reports ongoing opioid cravings.
5. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
6. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
7. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
8. Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
9. Negative blood cultures to rule out bacteremia

Exclusion criteria

1. Prior brain surgery
2. Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.
3. History of uncontrolled or persistent seizures
4. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
5. Contraindications for MRI:

   1. Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
   2. Claustrophobia
   3. Body weight exceeding limit of the machine (180 kg/400 lb)
6. Females who are pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test during the pre-op phase and must agree to utilize adequate birth control throughout the trial and for at least 30 days following trial completion.
7. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
8. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
9. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
10. Any evidence of underlying endocarditis.
11. Primary language other than English
12. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.

Where this trial is running

Pittsburgh, Pennsylvania

• AHN Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Nestor Tomycz, MD — Allegheny Health Network
• Study coordinator: Nestor Tomycz, MD

Conditions Opioid-use Disorder; Deep Brain Stimulation; Addiction; Nucleus Accumbens