Opioid-use DisorderNCT04354077
Deep Brain Stimulation Effects In Patients With Opioid Use Disorder
A study testing DBS of the NAc in people with Opioid-use Disorder, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- DBS of the NAc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) with at least a 5-year history
- OUD must be the primary disorder
- History of ongoing or previous opioid use, relapse, and/or cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.
- Self-reports ongoing opioid cravings.
- Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
- Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
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- Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
- Platelet count > 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
- Negative blood cultures to rule out bacteremia
Who cannot join
- Prior brain surgery contraindicating Deep Brain Stimulation (DBS) surgery, including procedures that required a craniotomy (e.g., brain tumor removal, trauma or pressure relief, hemorrhage, or clot evacuation). Patients with other brain surgery history will be considered and approved at the discretion of the Principal Investigator (PI).
- Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.
- History of uncontrolled or persistent seizures
- Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25
- Contraindications for MRI:
- Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
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- Claustrophobia
- Body weight exceeding limit of the machine (180 kg/400 lb)
- Females who are pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test during the pre-op phase and must agree to utilize adequate birth control throughout the trial and for at least 30 days following trial completion.
- Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
- Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
- Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
- Any evidence of underlying endocarditis.
- Primary language other than English
- Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, clinicaltrials@ahn.org
Nestor Tomycz, MD
About this study
Official title: Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
Read the detailed description
Three (N = 3) subjects with treatment refractory opioid use disorder will receive bilateral DBS implants in the NAc using the Abbott Medical Infinity DBS system. The primary outcome of this study is to demonstrate the safety of bilateral NAc DBS in patients with treatment-refractory opioid use disorder. Secondary outcomes include time to relapse, remission of opioid use, and change in opioid craving scores. Other secondary outcomes will include the following: Hamilton Depression Scale (HDS), neurophysiological tests, body weight and biochemical markers of health and nutrition. If effective, DBS may reduce opioid use and opioid relapse in people with opioid use disorder who may continue to display relapse despite ongoing multidisciplinary standard of care. DBS brain electrode implantation and implantation of the IPGs and extension wires will be done in the operating room and will require the subject to be admitted post-operatively for an overnight stay. Two weeks after the DBS operation, subjects will undergo systematic testing each of the quadripolar contacts and formal programming. Subsequent parameter settings will be changed at routine outpatient visits based on clinical effects. Standard of care can consist of methadone or buprenorphine maintenance treatment provided by an addiction specialist.
- Conditions
- Opioid-use Disorder
- Being tested
- DBS of the NAc
- Keywords
- Deep Brain Stimulation, Addiction, Nucleus Accumbens
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS of the NAcDevice
Also called Abbott Infinity DBS lead, model 6173ANS, Abbott Infinity DBS extension, model 6371ANS, Abbott Infinity DBS implantable pulse generator, model 6660ANS, Abbott Infinity DBS guardian burr hole cap, model 6010ANS
Deep Brain Stimulation of the Nucleus Accumbens
| Study group | Role | What they receive |
|---|---|---|
| NAc DBS | Experimental | Subjects will receive bilateral DBS of the NAc Receives: Device: DBS of the NAc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use/abstinence
Percentage of subjects achieving opioid abstinence
Measured: 6 months
Opioid use/abstinence
Percentage of subjects achieving opioid abstinence
Measured: 1 year post-surgery
Secondary outcomes (4)
Changes in biochemical markers of health
Biochemical battery of tests. Blood draw for plasma CBC, lytes, BUN, creatinine, Glutamate dehydrogenase (GLDH), gamma-glutamyltransferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), erythrocyte mean corpuscular volume (MCV), carbohydrate-deficient transferrin (CDT)
Measured: Baseline, 6, 12 and 24 months
Changes in biochemical markers of nutrition
Biochemical battery of tests. Blood draw for plasma, pre-albumin, folate, B12, calcium, magnesium, iron
Measured: Baseline, 6, 12 and 24 months
Depression score
Hamilton Depression Scale: There are 17 items by which an assessor will select one cue which best characterizes the patient (0-4). All items are added up for a total score, where lower numbers are indicative of a normal score and higher numbers are indicative of worse depression.
Measured: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Quality of life measure
Flanagan QOL scale: Subjects will assign a rank score to 16 items. Rankings go from 7 to 1, where 7 is a better outcome and 1 is the worst outcome. The scale is as follows: 7=Delighted, 6=Pleased, 5=Mostly Satisfied, 4=Mixed, 3=Mostly Dissatisfied, 2=Unhappy, 1=Terrible. All rankings are totaled for a final score.
Measured: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start7 Feb 2022
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Nestor Tomycz, MD, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354077
- Sponsor's protocol ID
- Addiction DBS
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients With Treatment-refractory Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04354077
- Acronym / sponsor ID
- Addiction DBS
- Conditions
- Opioid-use Disorder
- Keywords
- Deep Brain Stimulation, Addiction, Nucleus Accumbens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Abbott
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
Detailed description
Three (N = 3) subjects with treatment refractory opioid use disorder will receive bilateral DBS implants in the NAc using the Abbott Medical Infinity DBS system. The primary outcome of this study is to demonstrate the safety of bilateral NAc DBS in patients with treatment-refractory opioid use disorder. Secondary outcomes include time to relapse, remission of opioid use, and change in opioid craving scores. Other secondary outcomes will include the following: Hamilton Depression Scale (HDS), neurophysiological tests, body weight and biochemical markers of health and nutrition. If effective, DBS may reduce opioid use and opioid relapse in people with opioid use disorder who may continue to display relapse despite ongoing multidisciplinary standard of care. DBS brain electrode implantation and implantation of the IPGs and extension wires will be done in the operating room and will require the subject to be admitted post-operatively for an overnight stay. Two weeks after the DBS operation, subjects will undergo systematic testing each of the quadripolar contacts and formal programming. Subsequent parameter settings will be changed at routine outpatient visits based on clinical effects. Standard of care can consist of methadone or buprenorphine maintenance treatment provided by an addiction specialist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAc DBS | Experimental | Device: DBS of the NAcSubjects will receive bilateral DBS of the NAc |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and females age ≥ 22 years with diagnosis of opioid use disorder (OUD) based on Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) with at least a 5-year history
- OUD must be the primary disorder
- History of ongoing or previous opioid use, relapse, and/or cravings, despite attempts at, or attendance in, at least two different treatment modalities. These modalities may include: Comprehensive Opioid Addiction Treatment (COAT), intensive outpatient COAT, residential treatment, inpatient treatment, alternative to intensive outpatient programs, Drug Dependence Unit programs, medication-assisted treatment (MAT), medication assisted recovery (MAR), inpatient or outpatient rehabilitation, detox programs, Narcotics Anonymous, individual or group therapy, Partial Hospitalization Programs (PHP), Sober living homes, or similar interventions.
- Self-reports ongoing opioid cravings.
- Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
Key exclusion criteria (15 listed)
- Prior brain surgery contraindicating Deep Brain Stimulation (DBS) surgery, including procedures that required a craniotomy (e.g., brain tumor removal, trauma or pressure relief, hemorrhage, or clot evacuation). Patients with other brain surgery history will be considered and approved at the discretion of the Principal Investigator (PI).
- Baseline assessment on the Hamilton Depression Rating Scale (HAMD) of greater than 17 or moderate risk of suicide based upon a score of 3 or greater on the Columbia Suicide Severity Scale, unless clinical judgment indicates that the individual is appropriate for inclusion despite these scores.
- History of uncontrolled or persistent seizures
- Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25
- Contraindications for MRI:
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 |
|---|---|---|
| DBS of the NAcAlso: Abbott Infinity DBS lead, model 6173ANS, Abbott Infinity DBS extension, model 6371ANS, Abbott Infinity DBS implantable pulse generator, model 6660ANS, Abbott Infinity DBS guardian burr hole cap, model 6010ANSDeep Brain Stimulation of the Nucleus Accumbens | Device | NAc DBS |
Primary outcome
Opioid use/abstinence
Time frame: 6 months
Percentage of subjects achieving opioid abstinence
Opioid use/abstinence
Time frame: 1 year post-surgery
Percentage of subjects achieving opioid abstinence
4 secondary outcomes
Changes in biochemical markers of health
Time frame: Baseline, 6, 12 and 24 months
Changes in biochemical markers of nutrition
Time frame: Baseline, 6, 12 and 24 months
Depression score
Time frame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Quality of life measure
Time frame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
Nestor Tomycz, MD principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS of the NAc in people with Opioid-use Disorder, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 31 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nestor Tomycz, MD (412-359-6200, nestor.tomycz@ahn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use/abstinence (time frame: 6 months). 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 31 Aug 2026.