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

February 12, 2026 updated by: West Virginia University

A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University Rockefeller Neuroscience Institute

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DBS-ON Only
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
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.
Sham Comparator: DBS-OFF, then DBS-ON
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability as Measured by All Adverse Events Related to DBS
Time Frame: Outpatient Week 12
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
Time Frame: Outpatient Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Brain Reward Circuitry (FDG PET)
Time Frame: Change from Baseline versus Outpatient Week 12
Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)
Change from Baseline versus Outpatient Week 12
Changes in the Brain Reward Circuitry (Fallypride PET)
Time Frame: Change from Baseline versus Outpatient Week 12
Changes in the reward circuitry via evaluating dopamine in the basal ganglia and NAc (18F-fallypride PET).
Change from Baseline versus Outpatient Week 12
Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)
Time Frame: Change from Baseline versus Outpatient Week 12

Substance craving without cues: Substance craving will be assessed using a visual analog scale (VAS) where participants are asked to rate their craving. Participants will be asked "How much do you crave [insert substance name] right now?".

Scale: 0 to 10 where 0 = no craving and 10 = maximum craving
Change from Baseline versus Outpatient Week 12
Changes in Cue-Induced Substance Craving (Visual Analog Scale)
Time Frame: Change from Baseline versus Outpatient Week 12

Substance craving with cues (via a cue reactivity task): A set of substance-related stimuli (e.g., photos, computer images) will be presented to the participant. Prior to and immediately after viewing the cues, participants will complete computer-based assessment VAS designed to assess craving. Participants will be asked "How much do you crave [insert substance name] right now?".

Scale: 0 to 10 where 0 = no craving and 10 = maximum craving
Change from Baseline versus Outpatient Week 12
Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)
Time Frame: Change from Baseline versus Outpatient Week 12

Mood and emotional functioning (depression and anxiety) assessed via the Comprehensive Psychopathological Rating Scale (CPRS)

Scale: 0 - 108 where 0 = no distress and 108 = severe distress
Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)
Time Frame: Change from Baseline versus Outpatient Week 12
Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB)
Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (Standard Neuropsychological Battery)
Time Frame: Change from Baseline versus Outpatient Week 12
Cognitive Functioning assessed via the standard neuropsychological battery (e.g., WAIS-IV)
Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)
Time Frame: Change from Baseline versus Outpatient Week 12
Cognitive Functioning assessed via the experimental measures of executive functioning (e.g., Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting).
Change from Baseline versus Outpatient Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Study Director: James Mahoney, PhD, WVU Rockefeller Neuroscience Institute

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 Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

October 17, 2023

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2301715195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid-Related Disorders

Clinical Trials on Deep Brain Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe