Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

NCT03950492 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: 19034998411UG3DA047714-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to investigate the safety, tolerability, and feasibility of Deep Brain Stimulation (DBS) of the nucleus accumbens (NAc) and ventral internal capsule (VC) for participants with treatment refractory opioid use disorder (OUD) who have cognitive, behavioral, and functional disability. This study will also provide critical information for planning subsequent clinical trials.

Conditions

Opioid-Related Disorders

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Total Number of Study-Emergent Adverse Events

  Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.

  Enrollment - 52 weeks

• Change in Opioid Use

  Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.

  12 weeks

Secondary Outcomes (4)

• Participant Survival

  12 -52 weeks

• Treatment Retention

  12 - 52 weeks

• Incidence of Serious Infectious Disease Complications

  12 - 52 weeks

• Mood, Craving and Executive Function

  12 and 24 weeks post surgery

Other Outcomes (2)

• Frontal Lobe Metabolism

  3 weeks and 12 weeks post surgery

• Changes in Dopamine

  3 weeks and 12 weeks post surgery

Study Arms (1)

OUD DBS

EXPERIMENTAL

This is a single arm study. Participants will be followed in an inpatient service for two weeks to gather baseline data followed by DBS placement and up to 6 weeks inpatient for clinical stabilization and DBS titration. All participants will then be followed twice a week for 12 weeks in the outpatient setting and then once a week for a total of 52 weeks post-titration.

Device: Deep Brain Simulator

Interventions

Deep Brain Simulator DEVICE

This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.

OUD DBS

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fulfills current DSM-5 (American Psychiatric Association Diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for OUD (severe) and at least a 5-year history.
• Participants may have comorbid SUD diagnoses at mild, moderate or severe levels, however OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse
• Failed at least two levels of treatment (outpatient/Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient/intensive COAT, residential, inpatient, Adult Intensive Outpatient Program (AIOP), Dual Diagnosis Unit (DDU), which included buprenorphine/naloxone.
• At least two overdose survivals or one overdose survival and one life-threatening infectious disease complication with relapse after treatment (e.g., endocarditis with valve repair/replacement) within the past 1 year.
• Family/Social Support/Involvement (as assessed via the Multidimensional Scale of Perceived Social Support).
• Is able to provide informed consent.

You may not qualify if:

• Medical problems requiring intensive medical or diagnostic management.
• Diagnosis of acute myocardial infarction or cardiac arrest within the previous 6 months.
• History of a neurosurgical ablation procedure.
• Any medical contraindications to undergoing DBS surgery.
• History of hemorrhagic stroke.
• Life expectancy of \<3 years
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced (assessed via SCID-5). Any treated depression has to have been in remission for one year.
• 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.
• Cluster A or B Personality Disorders.
• Diagnosis of dementia.
• History of neurological disorder.
• History of previous neurosurgery (brain) or head trauma.
• History of suicide attempt.
• Parental history of completed suicide.
• Abnormal coagulation lab studies or uncontrolled hypertension.

Sponsors & Collaborators

• West Virginia University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Medtronic: collaborator

Study Sites (1)

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Rezai AR, Mahoney JJ, Ranjan M, Haut MW, Zheng W, Lander LR, Berry JH, Farmer DL, Marton JL, Tirumalai P, Mears A, Thompson-Lake DGY, Finomore VS, D'Haese PF, Aklin WM, George DT, Corrigan JD, Hodder SL. Safety and feasibility clinical trial of nucleus accumbens deep brain stimulation for treatment-refractory opioid use disorder. J Neurosurg. 2023 Jun 9;140(1):231-239. doi: 10.3171/2023.4.JNS23114. Print 2024 Jan 1.

  PMID: 37329519 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: James Mahoney, PhD
• Organization: WVU Rockefeller Neuroscience Institute

james.mahoney@hsc.wvu.edu

304-293-5323

Study Officials

• Ali R Rezai, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have deep brain stimulation (DBS) targeting the NAc/VC.

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: September 30, 2019
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2025
• Results First Posted: June 25, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)