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Completed

NCT Number: NCT05903495

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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)

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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).

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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