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

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903495
• Other study ID #: 2301715195
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 2028

Study information

• Verified date: June 2023
• Source: West Virginia University
• Contact: Shannon Filburn, RN
• Phone: 304-293-6736
• Email: sfilburn[@]hsc.wvu.edu
• 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.

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: Recruiting
• Enrollment: 20
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

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.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Opioid use assessed via quantitative urine toxicology	Opioid use will be evaluated through the use of quantitative urine toxicology using gas chromatography/mass spectrometry. For each subject, quantitative urine toxicology will be collected at baseline (during screening) and during Outpatient Follow-Up Week 4, 8, and 12. The primary outcome comparison between the active and sham arms will be the percentage of participants with undetectable opioid metabolites (assessed via quantitative urine toxicology) throughout the primary Outpatient Week 12 endpoint.	Outpatient Week 12
Secondary	Changes in the Brain Reward Circuitry (FDG PET)	Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)	Change from Baseline versus Outpatient Week 12
Secondary	Changes in the Brain Reward Circuitry (Fallypride PET)	Changes in the reward circuitry via evaluating dopamine in the basal ganglia and NAc (18F-fallypride PET).	Change from Baseline versus Outpatient Week 12
Secondary	Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)	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
Secondary	Changes in Cue-Induced Substance Craving (Visual Analog Scale)	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
Secondary	Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)	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
Secondary	Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)	Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB)	Change from Baseline versus Outpatient Week 12
Secondary	Changes in Cognitive Functioning (Standard Neuropsychological Battery)	Cognitive Functioning assessed via the standard neuropsychological battery (e.g., WAIS-IV)	Change from Baseline versus Outpatient Week 12
Secondary	Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)	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