Deep Brain Stimulation for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Overseen byNestor Tomycz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Must be taking: Methadone, Buprenorphine, Suboxone
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Prior brain surgery, Seizures, Dementia, Pregnancy, others
Stay on Your Current Meds
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial tests a brain device that sends electrical signals to help people with severe opioid addiction who don't respond to usual treatments. The device aims to reduce cravings and prevent relapse by targeting a specific brain area involved in addiction.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have active illicit substance abuse and must be part of a medication-assisted treatment program, which may include methadone or buprenorphine.
What data supports the effectiveness of this treatment for opioid use disorder?
Research suggests that deep brain stimulation (DBS) of the nucleus accumbens (NAc) may help reduce addictive behaviors, as seen in animal studies where it decreased addiction to substances like alcohol and cocaine. Additionally, some small clinical studies have shown promising results in humans, but larger studies are needed to confirm its effectiveness for opioid use disorder.12345
Is deep brain stimulation of the nucleus accumbens safe for humans?
Deep brain stimulation (DBS) of the nucleus accumbens has been studied for various conditions, including addiction and psychiatric disorders. In a study involving a person with severe opioid and benzodiazepine use disorders, DBS was found to be safe with no serious side effects. Additionally, animal studies and initial human trials suggest that DBS of this brain area is generally safe.12678
How is deep brain stimulation different from other treatments for opioid use disorder?
Deep brain stimulation (DBS) is unique because it involves surgically implanting electrodes in the brain to modulate neural activity, specifically targeting the nucleus accumbens, a key area involved in addiction. Unlike traditional treatments like medication or therapy, DBS is reversible, adjustable, and minimally invasive, offering a novel approach for those with treatment-resistant opioid dependence.12345
Eligibility Criteria
This trial is for adults over 22 with a primary diagnosis of opioid use disorder (OUD) based on DSM-V, who have struggled with OUD for at least 5 years and failed multiple treatments. Participants must not have severe psychiatric disorders or other substance abuse issues, should be in good physical health without serious infections or blood clotting problems, and cannot be pregnant.Inclusion Criteria
Has completed a neuro-psychological evaluation to the satisfaction of a neuropsychologist
OUD must be the primary disorder
Negative blood cultures to rule out bacteremia
See 7 more
Exclusion Criteria
I have severe brain shrinkage or fluid/blood under my skull's lining.
I have signs of heart valve infection.
Have any other medical condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment
See 12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery and Initial Recovery
Participants undergo DBS brain electrode implantation and are admitted post-operatively for an overnight stay
1 week
1 visit (in-person, surgical)
Post-Surgery Programming and Adjustment
Two weeks after surgery, subjects undergo systematic testing and programming of DBS settings
2 weeks
Multiple visits (in-person)
Treatment
Participants receive ongoing DBS treatment with routine outpatient visits for parameter adjustments
24 months
Routine outpatient visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Treatment Details
Interventions
- DBS of the NAc (Device)
Trial OverviewThe study tests deep brain stimulation (DBS) of the nucleus accumbens (NAc) as an additional treatment for those with hard-to-treat opioid addiction. It will include only three individuals who continue to relapse despite being in a drug treatment program.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NAc DBSExperimental Treatment1 Intervention
Subjects will receive bilateral DBS of the NAc
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AHN Allegheny General HospitalPittsburgh, PA
Loading ...
Who Is Running the Clinical Trial?
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
AbbottIndustry Sponsor
References
Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study. [2020]Deep brain stimulation (DBS) is a new potential surgical treatment for opioid dependence. However, the implement of DBS treatment in addicted patients is currently controversial due to the significant associated risks. The aim of this study was mainly to investigate the therapeutic efficacy and safety of bilateral DBS of nucleus accumbens and the anterior limb of the internal capsule (NAc/ALIC-DBS) in patients with refractory opioid dependence (ROD).
Nucleus Accumbens as a Novel Target for Deep Brain Stimulation in the Treatment of Addiction: A Hypothesis on the Neurochemical and Morphological Basis. [2020]Addiction is a major cause of mortality and morbidity. Apart from psychotropic substances, alcohol and nicotine remain the common addictive materials responsible for the majority of deaths. Conventional conservative therapies are beneficial to certain populations, but the majority may require interventional treatments such as deep brain stimulation (DBS) in view of increasing mortality from drug abuse in recent years. We present a brief review on a novel neuromodulation target of the nucleus accumbens (NA) and its promising role in the management of addiction. The three stages of the addiction cycle are known to be mediated by dopaminergic pathways located in the mesolimbic dopamine system with connections to dorsal striatum, extended amygdala, cingulate gyrus, orbitofrontal cortex, prefrontal cortex, and ventral tegmental area. Recent advanced neuroimaging in humans and several animal studies demonstrated NA to be a vital anatomical area modulating this network. DBS of NA in animals reduced addictive behavior to alcohol, cocaine, and other narcotics significantly. The accidental observation that DBS of NA for psychiatric illnesses induced relief from addiction to alcohol and smoking has encouraged further research of late. Bilateral NA ablative surgery had shown nonrelapse in more than 50% of cases. Small series of patients have benefited so far from DBS of NA, but larger numbers are required to provide evidence-based treatment. The modulation of dopaminergic pathways through DBS of NA as a valid treatment for addiction is substantiated extensively by animal studies and also in a few clinical studies. However, this needs to be validated by a well-structured, multicenter controlled study in a large group of patients suffering from substance abuse.
The Effect of High-Frequency Electrical Stimulation of Bilateral Nucleus Accumbens on the Behavior of Morphine-Induced Conditioned Place Preference Rats at Extinction and Reinstatement Phases. [2022]To explore the optimal time points for deep brain stimulation (DBS) on the treatment of morphine addiction and its possible mechanisms by investigating how high-frequency stimulation (HFS) in bilateral nucleus accumbens (NAc) at different time points influences the addictive behaviors of rats with drug addiction.
Nucleus accumbens as a stereotactic target for the treatment of addictions in humans: a literature review. [2021]Deep brain stimulation (DBS) has achieved substantial success as a treatment for movement disorders such as Parkinson's Disease (PD), essential tremor (ET), and dystonia. More recently, a limited number of basic and clinical studies have indicated that DBS of the nucleus accumbens (NAc) and other neighbouring structures of the reward circuit may be an effective intervention for patients with treatment-refractory addiction.
Inhibition of the reinstatement of morphine-induced place preference in rats by high-frequency stimulation of the bilateral nucleus accumbens. [2013]Opiate addiction remains intractable in a large percentage of patients, and relapse is the biggest hurdle to recovery. Many studies have identified a central role of the nucleus accumbens (NAc) in addiction. Deep brain stimulation (DBS) has the advantages of being reversible, adjustable, and minimally invasive, and it has become a potential neurobiological intervention for addiction. The purpose of our study was to investigate whether high-frequency DBS in the NAc effectively attenuates the reinstatement of morphine seeking in morphine-primed rats.
The nucleus accumbens and alcoholism: a target for deep brain stimulation. [2021]Alcohol use disorder (AUD) is a difficult to treat condition with a significant global public health and cost burden. The nucleus accumbens (NAc) has been implicated in AUD and identified as an ideal target for deep brain stimulation (DBS). There are promising preclinical animal studies of DBS for alcohol consumption as well as some initial human clinical studies that have shown some promise at reducing alcohol-related cravings and, in some instances, achieving long-term abstinence. In this review, the authors discuss the evidence and concepts supporting the role of the NAc in AUD, summarize the findings from published NAc DBS studies in animal models and humans, and consider the challenges and propose future directions for neuromodulation of the NAc for the treatment of AUD.
Deep brain stimulation of the bilateral nucleus accumbens in normal rhesus monkey. [2012]The nucleus accumbens (NAc) has been considered as a novel target of deep brain stimulation (DBS) for intractable psychiatric disorders. Quite a few questions exist about this new treatment, and might be explored in nonhuman primate models. There are several reports on DBS of brain nucleus other than NAc in nonhuman primates. Therefore, we stereotactically implanted the electrodes into bilateral NAc under the guidance of MRI using a clinical Leksell stereotactic system in normal rhesus monkeys. NAc could be recognized as the area of continuity between the caudate nucleus and putamen in the coronal sections, which is beneath the internal capsule, and the gray matter nucleus between the ventromedial prefrontal cortex and anterior commissure in axial sections, which is medial to the putamen. NAc is mainly at a point 2.0-3.0 mm inferior, 3.0-4.0 mm anterior, and 4.5-5.5 mm lateral to the anterior commissure. The electrodes were implanted accurately and connected to an implantable pulse generator subcutaneously. After recovery from surgery, stimulation with a variety of parameters was trialed, and continuous stimulation at 90 μs, 3.5 V, 160, or 60 Hz was administered individually for 7 days. The behaviors and spontaneous locomotor activity of the animals did not change significantly during stimulation. This is the first report on DBS of NAc in nonhuman primates to the best of our knowledge. Bilateral electrical stimulation of NAc is a safe treatment. This model could be helpful in further studies on the clinical use of NAc stimulation for psychiatric disorders and for a better understanding of the functions of this nucleus.
Deep brain stimulation of the nucleus accumbens/ventral capsule for severe and intractable opioid and benzodiazepine use disorder. [2022]Given high relapse rates and the prevalence of overdose deaths, novel treatments for substance use disorder (SUD) are desperately needed for those who are treatment refractory. The objective of this study was to evaluate the safety of deep brain stimulation (DBS) for SUD and the effects of DBS on substance use, substance craving, emotional symptoms, and frontal/executive functions. DBS electrodes were implanted bilaterally within the Nucleus Accumbens/Ventral anterior internal capsule (NAc/VC) of a man in his early 30s with >10-year history of severe treatment refractory opioid and benzodiazepine use disorders. DBS of the NAc/VC was found to be safe with no serious adverse events noted and the participant remained abstinent and engaged in comprehensive treatment at the 12-week endpoint (and 12-month extended follow-up). Using a 0-100 visual analog scale, substance cravings decreased post-DBS implantation; most substantially in benzodiazepine craving following the final DBS titration (1.0 ± 2.2) compared to baseline (53.4 ± 29.5; p