Opioid-Related DisordersNCT05903495
Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
A study testing Deep Brain Stimulation in people with Opioid-Related Disorders, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 50 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
About this study
Official title: A Randomized, Sham-Controlled Trial Investigating 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.
Read the 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Deep Brain Stimulation |
| 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. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Outpatient Week 12
Secondary outcomes (8)
Changes in the Brain Reward Circuitry (FDG PET)
Changes in the reward circuitry via evaluating prefrontal cortex glucose metabolism (FDG PET)
Measured: Change from Baseline versus Outpatient Week 12
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).
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)
Cognitive Functioning assessed via NIH Toolbox Cognition Battery (NIHTB)
Measured: 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)
Measured: 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).
Measured: Change from Baseline versus Outpatient Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jul 2023
- Primary completion17 Oct 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James Mahoney, PhD, Study director, WVU Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903495
- Sponsor's protocol ID
- 2301715195
- Status last verified
- Aug 2025
- First submitted
- 11 May 2023
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Trial Investigating Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05903495
- Acronym / sponsor ID
- 2301715195
- Conditions
- Opioid-Related Disorders
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS-ON Only | Experimental | Device: Deep Brain StimulationTitration 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 | Device: Deep Brain StimulationTitration 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. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulationrandomized, sham-controlled, partial crossover study investigating DBS, targeting the nucleus accumbens (NAc) and ventral internal capsule (VC), for participants with severe, treatment refractory OUD. | Device | DBS-OFF, then DBS-ON, DBS-ON Only |
Primary outcome
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).
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.
8 secondary outcomes
Changes in the Brain Reward Circuitry (FDG PET)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in the Brain Reward Circuitry (Fallypride PET)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Non-Cue Induced Substance Craving (Visual Analog Scale)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Cue-Induced Substance Craving (Visual Analog Scale)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Mood and Emotional Functioning (Comprehensive Psychopathological Rating Scale)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (NIH Toolbox Cognition Battery)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (Standard Neuropsychological Battery)
Time frame: Change from Baseline versus Outpatient Week 12
Changes in Cognitive Functioning (Executive Functioning: Flanker, N-Back, Psychomotor Vigilance, Delayed Discounting)
Time frame: Change from Baseline versus Outpatient Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Mahoney, PhD study director
WVU Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Opioid-Related Disorders, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability as Measured by All Adverse Events Related to DBS (time frame: Outpatient Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.