Deep brain stimulation for opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 contraindicating Deep Brain Stimulation (DBS) surgery, including procedures that required a craniotomy (e.g., brain tumor removal, trauma or pressure relief, hemorrhage, or clot evacuation). Patients with other brain surgery history will be considered and approved at the discretion of the Principal Investigator (PI).
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 it's running

• AHN Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Nestor Tomycz, MD — Allegheny Health Network
• Study coordinator: Nestor Tomycz, MD
• Email: nestor.tomycz@ahn.org
• Phone: 412-359-6200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.