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

Opioid-Related Disorders Clinical Trial

— DBS_OUD  

Official title:

Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03950492
• Other study ID #: 1903499841
• Secondary ID: 1UG3DA047714-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The overarching goal of this study is to evaluate the safety, tolerability, feasibility and impact on outcomes of NAc/VC DBS for treatment refractory OUD. In treatment refractory OUD, innovative approaches and more invasive interventions including DBS are warranted to improve outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: December 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Implanted neurostimulators.

• Any current CNS infection or infection with the Human Immunodeficiency Virus (HIV).

• Unable to undergo MR-imaging.

• Documentation of MRI abnormality indicative of a neurological condition.

• Substance abuse treatment mandated by court of law.

• Pregnant or planning to become pregnant.

• Conditions requiring diathermy.

• Anticoagulant treatment.

• Primary language other than English.

• Any evidence of systemic infection.

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Device:
• Deep Brain Simulator
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.

Locations

Country	Name	City	State
United States	West Virginia University Rockefeller Neuroscience Institute	Morgantown	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
West Virginia University	Medtronic, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frontal Lobe Metabolism	18fluoro-Deoxy-Glucose (FDG) PET will be use to determine if there is an increase in frontal lobe metabolism following DBS	3 weeks and 12 weeks post surgery
Other	Changes in Dopamine	C11 Raclopride PET may be used to examine for changes in dopamine at 12 weeks post titration.	3 weeks and 12 weeks post surgery
Primary	Incidence of Study-Emergent Adverse Events	Study participants will be closely monitored for adverse events following DBS surgery with regular check-ups by study personnel.	24 - 52 weeks
Primary	Change in Opioid Use	Opioid use as measured by quantitative urine toxicology via high pressure liquid chromatography.	24 - 52 weeks
Secondary	Participant Survival	Incidence of drug overdose deaths among the participants.	12 -52 weeks
Secondary	Treatment Retention	Participants' retention in traditional medication assisted treatment (MAT).	12 - 52 weeks
Secondary	Incidence of Serious Infectious Disease Complications	Laboratory tests and evaluation to discern presentation of infectious disease.	12 - 52 weeks
Secondary	Mood, Craving and Executive Function	Participants will complete standardized measures of mood, drug craving, and executive function at 12 weeks and 24 weeks post DBS titration.	12 and 24 weeks post surgery