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

NCT05903495 | Completed Results DMC FDA Device

• 1 other identifier: 2301715195
• Study Type: interventional
• Target: 1
• 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.

Conditions

Opioid-Related Disorders

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability as Measured by All Adverse Events Related to DBS

  Incidence of Study-Emergent Adverse Events. The safety/tolerability primary endpoint will be assessed comparing Grade 3 and 4 adverse events between the Active (DBS-ON) and Sham (DBS-OFF) arms throughout Phase IV (Outpatient Week 12). We will also categorize adverse events by organ system and assess relatedness to any aspect of this proof-of-concept study. Statistical tests will be performed at the request of the Data and Safety Monitoring Board (DSMB).

  Outpatient Week 12

• Opioid Use Assessed Via Quantitative Urine Toxicology

  Opioid use will be evaluated through the use of quantitative urine toxicology using gas chromatography/mass spectrometry. The primary outcome comparison between the active and sham arms will be based off participants with undetectable opioid metabolites (assessed via quantitative urine toxicology) throughout the primary Outpatient Week 12 endpoint.

  Outpatient Week 12

Secondary Outcomes (8)

• Changes in the Brain Reward Circuitry (FDG PET)

  Change from Baseline versus Outpatient Week 12

• Changes in the Brain Reward Circuitry (Fallypride PET)

  Change from Baseline versus Outpatient Week 12

• Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)

  Change from Baseline versus Outpatient Week 12

• Changes in Cue-Induced Substance Craving (Visual Analog Scale)

  Change from Baseline versus Outpatient Week 12

• Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)

  Change from Baseline versus Outpatient Week 12

Study Arms (2)

DBS-ON Only

EXPERIMENTAL

Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment of OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team. Participants receive active stimulation after surgery and throughout the remaineder of the study.

Device: Deep Brain Stimulation

DBS-OFF, then DBS-ON

SHAM COMPARATOR

Titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered for the first 12 weeks and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

randomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD.

DBS-OFF, then DBS-ON; DBS-ON Only

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 22-50 years at time of enrollment.
• Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
• Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, 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.
• At least one lifetime overdose survival.
• Demonstrated greater than five years of refractory symptoms of OUD.

You may not qualify if:

• Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
• Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
• Unable to undergo MR-imaging

Sponsors & Collaborators

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

Study Sites (1)

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

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

james.mahoney@hsc.wvu.edu

304-293-5323

Study Officials

• James Mahoney, PhD

  WVU Rockefeller Neuroscience Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After completion of surgery, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (DBS-ON only) will have their stimulator turned on after recovering from surgery. Group B (DBS-OFF, then DBS-ON) will receive sham stimulation, meaning the stimulator will remain off until Study Week 12 of the outpatient phase, at which time the stimulator will be turned on and left on for the remainder of the study. Group A will continue to receive stimulation and not have the stimulator turned off. Participant and assessor will not know which group are assigned to until Study Week 12.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: October 17, 2023
• Study Completion: June 28, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)