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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in the Brain Reward Circuitry (Fallypride PET) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Mahoney, PhD | WVU Rockefeller Neuroscience Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Rockefeller Neuroscience Institute | Morgantown | West Virginia | 26505 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 remainder of the study. 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. |
| FG001 | 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 (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one participant enrolled in the study; assigned to the DBS-ON Only arm. No additional participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 remainder of the study. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Only one participant enrolled in the study; assigned to the DBS-ON arm. No additional participants were enrolled. | Posted | Number | Adverse Events | Outpatient Week 12 |
|
Outpatient Week 12
Participants were evaluated for AEs from the time consent was obtained until study closure or study exit. AEs were assessed at each visit and via self-report. The following were not considered AEs:
Inefficient DBS reprogramming Temporary stimulation-related effects during programming Expected postoperative symptoms, unless significant Worsened pre-existing conditions Unrelated medical/surgical procedures Routine battery replacement Non-medically significant technical observations/events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 remainder of the study. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Mahoney, PhD | WVU Rockefeller Neuroscience Institute | 304-293-5323 | james.mahoney@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2025 | Aug 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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.
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) | 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) | 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) | 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) | Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB) | Change from Baseline versus Outpatient Week 12 |
| 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 |
| 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 |
| BG001 | 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 (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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 (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. 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. |
|
|
| 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. 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. | Only one participant enrolled in the study; assigned to the DBS-ON arm. No additional participants were enrolled. | Posted | Number | participants | 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) | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| 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). | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| 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 | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| 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 | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| 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 | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| Secondary | Changes in Cognitive Functioning (NIH Toolbox Cognition Battery) | Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB) | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| Secondary | Changes in Cognitive Functioning (Standard Neuropsychological Battery) | Cognitive Functioning assessed via the standard neuropsychological battery (e.g., WAIS-IV) | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
| 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). | Not Posted | Change from Baseline versus Outpatient Week 12 | Participants |
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| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 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 (post surgery) and therefore, no actual adjustments made. At Study Week 12, stimulation is turn on and continues for the remainder of the study. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| Fractured Molar (x2) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hyperkalemia | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Intermittent Hypertension | Cardiac disorders | Systematic Assessment |
|
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