Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

August 27, 2026 updated by: Nestor Tomycz, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • AHN Allegheny General Hospital
        • Sub-Investigator:
          • Carol Schramke, PhD
        • Sub-Investigator:
          • Amanda Webb, PA
        • Sub-Investigator:
          • Stuart Fisk, CRNP
        • Principal Investigator:
          • Nestor Tomycz, MD
        • Sub-Investigator:
          • Donald Whiting, MD
        • Sub-Investigator:
          • Heather Richards, MD
        • Sub-Investigator:
          • Elizabeth Cuevas, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. 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
  2. OUD must be the primary disorder
  3. 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.
  4. Self-reports ongoing opioid cravings.
  5. Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
  6. Has completed a psychiatric evaluation to the satisfaction of a psychiatrist
  7. Has had a brain MRI performed and reviewed by neurosurgeon with no contraindication for DBS procedure identified
  8. Platelet count > 125,000 per cubic mm and prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
  9. Negative blood cultures to rule out bacteremia

Exclusion criteria

  1. 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).
  2. 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.
  3. History of uncontrolled or persistent seizures
  4. Suspected dementia based on neuropsychological screening or Mini Mental State Exam (MMSE) Score < 25

  5. Contraindications for MRI:

    1. Presence of implanted electrical stimulation device or other implanted metal devices (excluding dental braces).
    2. Claustrophobia
    3. Body weight exceeding limit of the machine (180 kg/400 lb)
  6. 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.
  7. Coagulopathy secondary to chronic need for anticoagulation medicine (e.g. warfarin) or anti-platelet medication (e.g. aspirin or clopidogrel)
  8. Diagnosis of neurological disorders (e.g. multiple sclerosis, Parkinson's disease, and stroke)
  9. Severe brain atrophy or presence of subdural hygromas or subdural hematomas on brain MRI
  10. Any evidence of underlying endocarditis.
  11. Primary language other than English
  12. Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NAc DBS
Subjects will receive bilateral DBS of the NAc
Device: DBS of the NAc
Deep Brain Stimulation of the Nucleus Accumbens
Other Names:
  • 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
  • Abbott Infinity DBS patient controller, model 6883ANS
  • Abbott Infinity DBS clinician programmer, model 3872ANS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid use/abstinence
Time Frame: 6 months
Percentage of subjects achieving opioid abstinence
6 months
Opioid use/abstinence
Time Frame: 1 year post-surgery
Percentage of subjects achieving opioid abstinence
1 year post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in biochemical markers of health
Time Frame: Baseline, 6, 12 and 24 months
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)
Baseline, 6, 12 and 24 months
Changes in biochemical markers of nutrition
Time Frame: Baseline, 6, 12 and 24 months
Biochemical battery of tests. Blood draw for plasma, pre-albumin, folate, B12, calcium, magnesium, iron
Baseline, 6, 12 and 24 months
Depression score
Time Frame: Baseline, 3, 6, 9, 12 and 24 months post-surgery
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.
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
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.
Baseline, 3, 6, 9, 12 and 24 months post-surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Primary Safety Objective - Complication rates
Time Frame: 12 months
Adverse events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nestor Tomycz, MD, Allegheny Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Addiction DBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings