RECRUITING

Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

Conditions

Opioid-use Disorder Deep Brain Stimulation Addiction Nucleus Accumbens

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-07

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04354077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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-V) with at least a 5-year history 2. OUD must be the primary disorder 3. Failed at least two levels of treatment (Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential, inpatient, alternative to intensive outpatient program, Drug Dependence Unit, which included buprenorphine/naloxone or buprenorphine monotherapy. 4. Has exhibited more than 2 episodes of opioid use relapse in prior 12 months despite ongoing participation in MAT program, including either methadone or buprenorphine or suboxone 5. No active ilicit substance abuse as based on urine testing 6. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist 7. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist 8. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified 9. Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits 10. Negative blood cultures to rule out bacteremia	1. Prior brain surgery 2. Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or increased risk of suicide based upon any positive response on the Columbia Suicide Severity Scale 3. History of suicide attempt in the past 5 years 4. History of uncontrolled or persistent seizures 5. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25 6. 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) 7. 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. 8. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel) 9. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke) 10. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI 11. Any evidence of underlying endocarditis. 12. Primary language other than English 13. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.

Inclusion Criteria

Exclusion 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-V) with at least a 5-year history
2. OUD must be the primary disorder
3. Failed at least two levels of treatment (Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential, inpatient, alternative to intensive outpatient program, Drug Dependence Unit, which included buprenorphine/naloxone or buprenorphine monotherapy.
4. Has exhibited more than 2 episodes of opioid use relapse in prior 12 months despite ongoing participation in MAT program, including either methadone or buprenorphine or suboxone
5. No active ilicit substance abuse as based on urine testing
6. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
7. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
8. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
9. Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
10. Negative blood cultures to rule out bacteremia

1. Prior brain surgery
2. Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or increased risk of suicide based upon any positive response on the Columbia Suicide Severity Scale
3. History of suicide attempt in the past 5 years
4. History of uncontrolled or persistent seizures
5. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
6. 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)
7. 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.
8. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
9. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
10. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
11. Any evidence of underlying endocarditis.
12. Primary language other than English
13. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.

Contacts and Locations

Study Contact

Nestor Tomycz, MD

CONTACT

412-359-6200

nestor.tomycz@ahn.org

Donald Whiting, MD

CONTACT

412-359-6200

donald.whiting@ahn.org

Principal Investigator

Nestor Tomycz, MD

PRINCIPAL_INVESTIGATOR

Allegheny Health Network

Study Locations (Sites)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Collaborators and Investigators

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Nestor Tomycz, MD, PRINCIPAL_INVESTIGATOR, Allegheny Health Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-07

Study Completion Date2025-02

Study Record Updates

Study Start Date2022-02-07

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

Deep Brain Stimulation
Addiction
Nucleus Accumbens

Additional Relevant MeSH Terms

Opioid-use Disorder