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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deep Brain Stimulation

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Deep Brain Stimulation

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

West Virginia University Rockefeller Neuroscience InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

DBS-ON

DBS-OFF

Arm Description

Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment o OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team.

For participants randomized to the "DBS-OFF" condition, titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered and therefore, no actual adjustments made

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Changes in the Brain Reward Circuitry (FDG PET)

Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)

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).

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

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

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

Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)

Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB)

Changes in Cognitive Functioning (Standard Neuropsychological Battery)

Cognitive Functioning assessed via the standard neuropsychological battery (e.g., WAIS-IV)

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).

Full Information

NCT ID

NCT05903495

First Posted

May 11, 2023

Last Updated

July 14, 2023

Sponsor

West Virginia University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05903495

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

West Virginia University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders

Keywords

Deep Brain Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

After completion of surgery, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (DBS-ON) will have their stimulator turned on after recovering from surgery. Group B (DBS-OFF) 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.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DBS-ON

Arm Type

Experimental

Arm Description

Titration will be based on stimulation parameters used in previous studies examining the role of DBS of the NAc in the treatment o OCD and depression as well as the parameters utilized in the initial pilot study conducted by the team.

Arm Title

DBS-OFF

Arm Type

Sham Comparator

Arm Description

For participants randomized to the "DBS-OFF" condition, titration sessions will be conducted identically to the "DBS-ON" arm, the only difference is that no stimulation is delivered and therefore, no actual adjustments made

Intervention Type

Device

Intervention Name(s)

Deep Brain Stimulation

Intervention Description

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 Outcome Measure Information:

Title

Safety and tolerability as measured by all adverse events related to DBS

Description

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).

Time Frame

Outpatient Week 12

Title

Opioid use assessed via quantitative urine toxicology

Description

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.

Time Frame

Outpatient Week 12

Secondary Outcome Measure Information:

Title

Changes in the Brain Reward Circuitry (FDG PET)

Description

Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)

Time Frame