Deep Brain Stimulation for Opioid Use Disorder
Palo Alto (17 mi)Overseen byNestor Tomycz, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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.
Is deep brain stimulation a promising treatment for opioid use disorder?Yes, deep brain stimulation (DBS) is a promising treatment for opioid use disorder. It targets the nucleus accumbens, a key area in the brain's reward system, and has shown potential in reducing addictive behaviors. DBS is adjustable, reversible, and minimally invasive, making it a potential option for those who haven't responded to other treatments.24568
What safety data exists for deep brain stimulation for opioid use disorder?The safety of deep brain stimulation (DBS) for opioid use disorder has been evaluated in several studies. A multicenter, prospective, and double-blinded study aimed to investigate the safety and efficacy of DBS of the nucleus accumbens and anterior limb of the internal capsule in patients with refractory opioid dependence. Another study on a patient with severe opioid and benzodiazepine use disorder found DBS of the nucleus accumbens/ventral capsule to be safe, with no serious adverse events reported, and the patient remained abstinent at a 12-month follow-up. Additionally, animal studies, including those on rhesus monkeys, have shown that bilateral electrical stimulation of the nucleus accumbens is safe, with no significant changes in behavior or locomotor activity during stimulation. These findings suggest that DBS of the nucleus accumbens is a promising and safe treatment option for opioid use disorder, although larger studies are needed to confirm these results.13457
What data supports the idea that Deep Brain Stimulation for Opioid Use Disorder is an effective treatment?The available research shows that Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) may be an effective treatment for opioid use disorder. Studies have demonstrated that DBS can reduce addictive behaviors in animals, such as those addicted to alcohol and narcotics. Additionally, some small clinical studies in humans have shown promising results, with more than 50% of cases not experiencing relapse after treatment. However, larger studies are needed to confirm these findings. Compared to traditional therapies, DBS offers a reversible and adjustable option, which could be beneficial for those who do not respond to conventional treatments.24568
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you must not have active illicit substance abuse and should be participating in a medication-assisted treatment program, which may include methadone, buprenorphine, or suboxone.
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
I have relapsed on opioids more than twice in the last year despite being in a treatment program.
I have tried at least two different treatments for opioid addiction without success.
I am 22 or older and have been diagnosed with opioid use disorder for at least 5 years.
Exclusion Criteria
I have severe brain shrinkage or fluid/blood under my skull's lining.
I have signs of heart valve infection.
I have had brain surgery before.
I have a history of seizures that are not well-controlled.
I have a blood clotting disorder due to long-term use of blood thinners.
I have been diagnosed with a neurological disorder like MS, Parkinson's, or had a stroke.
Treatment Details
The 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.
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
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Who is running the clinical trial?
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
AbbottIndustry Sponsor
References
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.
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.
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.
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
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.