NCT04354077 Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
| NCT ID | NCT04354077 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
| Condition | Opioid-use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2022-02-07 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Nestor Tomycz, MD
PRINCIPAL INVESTIGATOR
Allegheny Health Network
Frequently Asked Questions
Who can join the NCT04354077 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Opioid-use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04354077 currently recruiting?
Yes, NCT04354077 is actively recruiting participants. Contact the research team at nestor.tomycz@ahn.org for enrollment information.
Where is the NCT04354077 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04354077 clinical trial?
NCT04354077 is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The principal investigator is Nestor Tomycz, MD at Allegheny Health Network. The trial plans to enroll 3 participants.