Clinical trial NCT05903495: Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Official title: A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Deep Brain Stimulation
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability as measured by all adverse events related to DBS
timeFrame: Outpatient Week 12
measure: Opioid use assessed via quantitative urine toxicology
timeFrame: Outpatient Week 12
Secondary outcomes:
measure: Changes in the Brain Reward Circuitry (FDG PET)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in the Brain Reward Circuitry (Fallypride PET)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Cue-Induced Substance Craving (Visual Analog Scale)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Cognitive Functioning (Standard Neuropsychological Battery)
timeFrame: Change from Baseline versus Outpatient Week 12
measure: Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)
timeFrame: Change from Baseline versus Outpatient Week 12
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: WVU Rockefeller Neuroscience Institute
name: James Mahoney, PhD
role: STUDY_DIRECTOR
References: