Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

NCT04354077 | Recruiting DMC FDA Device

• 1 other identifier: Addiction DBS
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

Deep Brain Stimulation; Addiction; Nucleus Accumbens

Outcome Measures

Primary Outcomes (2)

• Opioid use/abstinence

  Percentage of subjects achieving opioid abstinence

  6 months

• Opioid use/abstinence

  Percentage of subjects achieving opioid abstinence

  1 year post-surgery

Secondary Outcomes (4)

• Changes in biochemical markers of health

  Baseline, 6, 12 and 24 months

• Changes in biochemical markers of nutrition

  Baseline, 6, 12 and 24 months

• Depression score

  Baseline, 3, 6, 9, 12 and 24 months post-surgery

• Quality of life measure

  Baseline, 3, 6, 9, 12 and 24 months post-surgery

Other Outcomes (1)

• Primary Safety Objective - Complication rates

  12 months

Study Arms (1)

NAc DBS

EXPERIMENTAL

Subjects will receive bilateral DBS of the NAc

Device: DBS of the NAc

Interventions

DBS of the NAc DEVICE

Deep Brain Stimulation of the Nucleus Accumbens

Also known as: Abbott Infinity DBS lead, model 6173ANS, Abbott Infinity DBS extension, model 6371ANS, Abbott Infinity DBS implantable pulse generator, model 6660ANS, Abbott Infinity DBS guardian burr hole cap, model 6010ANS, Abbott Infinity DBS patient controller, model 6883ANS, Abbott Infinity DBS clinician programmer, model 3872ANS

NAc DBS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• OUD must be the primary disorder
• 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.
• Self-reports ongoing opioid cravings.
• Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
• Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
• Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
• Platelet count \> 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
• Negative blood cultures to rule out bacteremia

You may not qualify if:

• Prior brain surgery
• History of uncontrolled or persistent seizures
• Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score \< 25
• Contraindications for MRI:
• Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
• Claustrophobia
• Body weight exceeding limit of the machine (180 kg/400 lb)
• 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.
• Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
• Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
• Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
• Any evidence of underlying endocarditis.
• Primary language other than English
• Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.

Sponsors & Collaborators

• Abbott: collaborator
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Nestor Tomycz, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestor Tomycz, MD

CONTACT

412-359-6200; nestor.tomycz@ahn.org

Donald Whiting, MD

CONTACT

412-359-6200; donald.whiting@ahn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 21, 2020
• Study Start: February 7, 2022
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)