scholarly journals The Effect of Single High-dose Buprenorphine on Opioid Craving and Relapse

2019 ◽  
Author(s):  
Jamshid Ahmadi ◽  
Mina SefidfardJahromi ◽  
Dara Ghahremani ◽  
Edythe D. London
Keyword(s):  
Statistical Significance ◽  
Opioid Use Disorder ◽  
High Dose ◽  
Opioid Use ◽  
Single High Dose ◽  
Treatment Objective ◽  
High Doses ◽  
Long Acting ◽  
Drug Free

Abstract Background: Buprenorphine, a treatment for Opioid Use Disorder, has liability for diversion and abuse. Use of single high doses of buprenorphine that are supervised avoid issues with diversion that occur with unsupervised or take home doses. Such doses have the potential to act as an initial opioid detox, facilitate transition to opioid antagonists or drug free treatments, as well as to maintenance treatment. Objective: To assess effects of a single, physician-administered high dose of buprenorphine on craving and on early relapse. Method: Sixty men who used heroin, opium or prescription opioids and met DSM-5 criteria for Opioid Use Disorder received a single, sublingual dose of buprenorphine (32 mg, 64 mg or 96 mg; n’s = 20, 21, and 19) as inpatients on a psychiatric unit. Buprenorphine was administered when patients were in moderate opioid withdrawal (4-5 symptoms). Self-reports of craving were taken at baseline and daily for the next 13 days, and relapse was assessed 1 and 2 months. Findings: Craving was reduced from baseline in each of the three groups (p < 0.0005), but the doseXtime interaction did not reach statistical significance (p= 0.069). Follow-up assessments at 1- and 2-months indicated significantly lower relapse rates for the higher-dose groups than for the low-dose group (p < 0.05). Conclusions: A single high dose of buprenorphine provides rapid relief of opioid craving and positively impacts relapse rate in the initial 1- and 2-months of outpatient treatment. Further investigation of single high-dose buprenorphine for early treatment of patients with Opioid Use Disorder is warranted as an alternative when buprenorphine/naloxone or long-acting buprenorphine dosage forms are not available.

scholarly journals The Effect of Single High-dose Buprenorphine on Opioid Craving and Relapse

2019 ◽  
Author(s):  
Jamshid Ahmadi ◽  
Mina SefidfardJahromi ◽  
Dara Ghahremani ◽  
Edythe D. London
Keyword(s):  
Statistical Significance ◽  
Opioid Use Disorder ◽  
Opioid Withdrawal ◽  
High Dose ◽  
Opioid Use ◽  
Single High Dose ◽  
High Doses ◽  
Long Acting ◽  
Drug Free

Abstract Background: Buprenorphine, a treatment for Opioid Use Disorder, has liability for diversion and abuse. Use of single high doses of buprenorphine that are supervised avoid issues with diversion that occur with unsupervised or take home doses. Such doses have the potential to act as an initial opioid detox, facilitate transition to opioid antagonists or drug free treatments, as well as to maintenance treatment. Objective: To assess effects of a single, physician-administered high dose of buprenorphine on craving and on early relapse. Method: Sixty men who used heroin, opium or prescription opioids and met DSM-5 criteria for Opioid Use Disorder received a single, sublingual dose of buprenorphine (32 mg, 64 mg or 96 mg; n’s = 20, 21, and 19) as inpatients on a psychiatric unit. Buprenorphine was administered when patients were in moderate opioid withdrawal (4-5 symptoms). Self-reports of craving were taken at baseline and daily for the next 13 days, and relapse was assessed 1 and 2 months. Findings: Craving was reduced from baseline in each of the three groups (p < 0.0005), but the doseXtime interaction did not reach statistical significance (p= 0.069). Follow-up assessments at 1- and 2-months indicated significantly lower relapse rates for the higher-dose groups than for the low-dose group (p < 0.05). Conclusions: A single high dose of buprenorphine provides rapid relief of opioid craving and positively impacts relapse rate in the initial 1- and 2-months of outpatient treatment. Further investigation of single high-dose buprenorphine for early treatment of patients with Opioid Use Disorder is warranted as an alternative when buprenorphine/naloxone or long-acting buprenorphine dosage forms are not available. Keywords: Buprenorphine; opioid dependence; opioid withdrawal; craving

scholarly journals Using Microdosing to Induct Patients Into a Long-Acting Injectable Buprenorphine Depot Medication in Low Threshold Community Settings: A Case Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Joseph Tay Wee Teck ◽  
Alexander Baldacchino ◽  
Lauren Gibson ◽  
Con Lafferty
Keyword(s):  
Methadone Treatment ◽  
Opioid Use Disorder ◽  
High Dose ◽  
Opioid Use ◽  
Access To Treatment ◽  
Medication Assisted Treatment ◽  
Low Threshold ◽  
Healthcare Innovation ◽  
Long Acting

Healthcare innovation has never been more important as it is now when the world is facing up to the unprecedented challenges brought by the COVID-19 pandemic. Within addictions services in Scotland, the priority has been to tackle our rising drug related death rate by maintaining and improving access to treatment while protecting frontline workers and managing operational challenges as a result of the pandemic. We present here a case study of five patients with opioid use disorder whose treatment represents a confluence of three important Medication Assisted Treatment (MAT) service innovations. The first was a low threshold drop in and outreach MAT service to rapidly and safely initiate opiate replacement therapy (ORT). The second was the provision of a microdosing regimen to enable same day induction to oral buprenorphine while minimizing the risk of precipitated opioid withdrawals and/or treatment disengagement. The third was rapid transitioning to an injectable long-acting buprenorphine depot which reduced unnecessary face to face patient contact and treatment non-adherence. This case study of five patients highlights the valuable role that buprenorphine microdosing can play in making induction to long-acting buprenorphine depot feasible to a broader range of patients, including those on a high dose methadone treatment regime.

End Stage Chronic Pain (ESCP): Naming Complex Suffering in the Opioid Crisis Era

2020 ◽  
pp. 104990912096962
Author(s):  
George Comerci ◽  
Lisa Marr ◽  
Esme Finlay
Keyword(s):  
Chronic Pain ◽  
Opioid Use Disorder ◽  
High Dose ◽  
Opioid Use ◽  
Opioid Crisis ◽  
Dramatic Decline ◽  
Cdc Guidelines ◽  
Severe Chronic Pain ◽  
High Doses ◽  
End Stage

The “opioid crisis” stemming from overprescribing of prescription opioids describes an iatrogenic situation which has resulted in a rise in opioid use disorder (OUD) and overdose deaths. Many of these patients suffer from chronic non-cancer pain syndromes (CNCP) who have been injudiciously treated with opioids. Some patients with CNCP are treated successfully with opioids in accordance with modern guidelines. There is a very complex, small group of patients with CNCP who require higher than recommended dosages of opioids when other modalities and treatments have failed. We describe such a patient and believe that there is a subset of patients with unremitting suffering from chronic pain which we have called end-stage chronic pain (ESCP). These patients, despite receiving expert chronic pain care, often require high doses of opioids and suffer a dramatic decline in quality of life (QOL), function and an increase in their suffering when their opioids are tapered or discontinued. We have responded to the treatment of this group of patients by critically examining our approach to the use of opioids for their pain and attempting to reconcile high dose opioids in the setting of the Center for Disease Control (CDC) guidelines. We describe a patient with severe chronic pain from congenital spinal disease who experienced increased pain and suffering when his opioids were tapered. We will discuss our approach to this patient and in doing so discuss the concept of ESCP and proposed criteria for the use of high dose opioids in such patients.

Initiation of Long-Acting Opioids Following Hospital Discharge Among Medicare Beneficiaries

2021 ◽  
Author(s):  
Bhushan R Deshpande ◽  
Ellen P McCarthy ◽  
Yoojin Jung ◽  
Timothy S Anderson ◽  
Shoshana J Herzig
Keyword(s):  
Hospital Discharge ◽  
Hospice Care ◽  
Opioid Use Disorder ◽  
High Dose ◽  
Medicare Beneficiaries ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Short Acting ◽  
Long Acting

Guidelines recommend against initiating long-acting opioids during acute hospitalization, owing to higher risk of overdose and morbidity compared to short-acting opioid initiation. We investigated the incidence of long-acting opioid initiation following hospitalization in a retrospective cohort of Medicare beneficiaries with an acute care hospitalization in 2016 who were ≥65 years old, did not have cancer or hospice care, and had not filled an opioid prescription within the preceding 90 days. Among 258,193 hospitalizations, 47,945 (18.6%) were associated with a claim for a new opioid prescription in the week after hospital discharge: 817 (0.3%) with both short- and long-acting opioids, 125 (0.1%) with long-acting opioids only, and 47,003 (18.2%) with short-acting opioids only. Most long-acting opioid claims occurred in surgical patients (770 out of 942; 81.7%). Compared with beneficiaries prescribed short-acting opioids only, beneficiaries prescribed long-acting opioids were younger, had a higher prevalence of diseases of the musculoskeletal system and connective tissue, and had more known risk factors for opioid-related adverse events, including anxiety disorders, opioid use disorder, prior long-term high-dose opioid use, and benzodiazepine co-prescription. These findings may help target quality-improvement initiatives.

scholarly journals AB0601 RAPID AND SUSTAINED EFFICACY OF AN INDUCTION TREATMENT WITH A TRIPLE THERAPY INCLUDING HIGH-DOSE INTRAVENOUS IMMUNOGLOBULINS, METHOTREXATE AND GLUCOCORTICOIDS IN ANTI-3-HYDROXY-3-METHYLGLUTARYL-COENZYME A REDUCTASE MYOPATHY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1597.1-1597
Author(s):  
E. Treppo ◽  
M. Infantino ◽  
M. Benucci ◽  
V. Ravagnani ◽  
B. Palterer ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Antibody Titer ◽  
Intravenous Immunoglobulins ◽  
High Dose ◽  
Sustained Remission ◽  
Red Rice ◽  
Gradual Improvement ◽  
High Doses ◽  
High Dose Ivig

Background:Anti-3-hydroxy-3-methylglutaryl-coenzime A reductase (HMGCR) myopathy is a new entity, which has been clearly associated to statin use, even if it can be diagnosed in patients without a history of exposure to statin or even in the childhood (1).Objectives:The aim of the study is to describe the efficacy of a triple therapy regimen consisting in high-doses of intravenous immunoglobulins (IVIG), methotrexate (MTX), and glucocorticoids (GC) in 16 patients with Anti-HMGCR myopathy enrolled in 6 specialized centres.Methods:A total of 16 patients with anti-HMGCR myopathy (7 females; 9 males) were collected. Mean (±standard deviation) age at the onset of disease was 72.4±10.3 years old. All patients were diagnosed having anti-HMGCR myopathy [anti-HMGCR antibodies were measured by chemiluminescence assay (BioFlash, Inova, CA)] (2). Median follow-up was 29.5 months (interquartile range: 15.75-60 months). Anti-HMGCR antibodies were available in the follow-up in 8/16 patients.Results:Thirteen out of 16 patients (81.3%) had been exposed to statin (1/13 to red rice), 3/16 (18.7%) were not exposed. As induction therapy, 11/16 patients have been treated with triple therapy (high-dose IVIG, MTX and GC), 2/16 with double therapy (high-dose IVIG and GC), 2/16 have been treated with GC alone, the patient exposed to red rice resolved only with red rice suspension. Clinical remission and normalization of CPK values within month +24 were obtained in all the patients. All the patients were in remission at the last follow-up. Gradual improvement started soon from the first month, and among the 13 patients treated with an aggressive immunosuppresssive therapy including IVIG (13/13), GC (13/13) and methotrexate (11/13), 9/13 normalized the CPK value within 6 months. Clinical and laboratory response was accompanied by significant decrease or normalization of the anti-HMGCR antibody titer. All the patients were either not taking GC (56.3%), or were taking low doses of GC (43.7%) at the last follow-up. Four patients had stopped GC within 6 months. No serious side effects were recorded. After persistent remission, a maintenance immunosuppressive therapy was then administered. Only 3 relapses in 3 different cases were recorded, all of them during drug-free remission in long-term follow-up. Reinduction was again effective in all.Conclusion:Anti-HMGCR myopathy is a rare and serious myopathy which usually affects older people during statin treatment. After statin suspension, a rapid and sustained remission can be achieved by induction with a triple aggressive therapy consisting in medium-to high doses of GC, high-dose IVIG, and MTX (3). GC should be tapered as soon as possible. Relapse appears infrequent during maintenance treatment. Monitoring anti-HMGCR antibody titer may be clinically relevant.References:[1]AL Mammen et al. N Engl J Med. 2016;374:664-9[2]Musset L et al. Autoimmun Rev. 2016;15:983-93.[3]Aggarwal A et al. Scand J Rheumatol. 2019; 1-7.Acknowledgments:We thank MD Francesca Grosso and MD Valentina Mecheri from the University of Florence, MD Angela Zuppa and MD Chiara De Michelis, from San Martino Hospital, Genova, for their valued collaboration in data collectionDisclosure of Interests:Elena Treppo: None declared, Maria Infantino: None declared, Maurizio Benucci: None declared, Viviana Ravagnani: None declared, Boaz Palterer: None declared, Marina Grandis: None declared, Martina Fabris: None declared, Paola Tomietto: None declared, Mariangela Manfredi: None declared, Arianna Sonaglia: None declared, Maria Grazia Giudizi: None declared, Francesca Ligobbi: None declared, Daniele Cammelli: None declared, Paola Parronchi: None declared, Salvatore De Vita Consultant of: Roche, GSK, Speakers bureau: Roche, GSK, Novartis, Luca Quartuccio Consultant of: Abbvie, Bristol, Speakers bureau: Abbvie, Pfizer

scholarly journals Predictors of availability of long-acting medication for opioid use disorder

2019 ◽  
Vol 204 ◽  
pp. 107586 ◽  
Author(s):  
Chelsea L. Shover ◽  
Keith Humphreys
Keyword(s):  
Opioid Use Disorder ◽  
Opioid Use ◽  
Long Acting

scholarly journals Buprenorphine exposure alters the development and migration of interneurons in the cortex

2020 ◽  
Author(s):  
Vanesa Nieto-Estévez ◽  
Jennifer J. Donegan ◽  
Courtney McMahon ◽  
Hannah B. Elam ◽  
Teresa A. Chavera ◽  
...  
Keyword(s):  
Human Brain ◽  
Fetal Brain ◽  
Opioid Use Disorder ◽  
Prescription Opioid ◽  
Opioid Use ◽  
Child Bearing ◽  
Increased Risk ◽  
Adverse Neonatal Outcomes ◽  
And Migration ◽  
Long Acting

ABSTRACTThe misuse of opioids has reached epidemic proportions over the last decade, with over 2.1 million people in the U.S. suffering from substance use disorders related to prescription opioid pain relievers. This increase in opioid misuse affects all demographics of society, including women of child-bearing age, which has led to a rise in opioid use during pregnancy. Opioid use during pregnancy has been associated with increased risk of obstetric complications and adverse neonatal outcomes, including neonatal abstinence syndrome. Currently, opioid use disorder in pregnant women is treated with long-acting opioid agonists, including buprenorphine. Although buprenorphine reduces illicit opioid use during pregnancy and improves infant outcomes at birth, few long-term studies of the neurodevelopmental consequences have been conducted. The goal of the current experiments was to examine the effects of buprenorphine on the development of the cortex using fetal brain tissue, 3D brain cultures, and rodent models. First, we demonstrated that we can grow cortical and subpallial spheroids, which model the cellular diversity, connectivity, and activity of the developing human brain. Next, we show that cells in the developing human cortex express the nociceptin opioid (NOP) receptor and that buprenorphine can signal through this receptor in cortical spheroids. Using subpallial spheroids to grow inhibitory interneurons, we show that buprenorphine can alter interneuron development and migration into the cortex. Finally, using a rodent model of prenatal buprenorphine exposure, we demonstrate that alterations in interneuron distribution can persist into adulthood. Together, these results suggest that more research is needed into the long-lasting consequences of buprenorphine exposure on the developing human brain.

scholarly journals Early innovations in opioid use disorder treatment and harm reduction during the COVID-19 pandemic: a scoping review

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Noa Krawczyk ◽  
Adetayo Fawole ◽  
Jenny Yang ◽  
Babak Tofighi
Keyword(s):  
Harm Reduction ◽  
Scoping Review ◽  
English Language ◽  
Data Extraction ◽  
Home Delivery ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Policy And Practice ◽  
Patient Centered ◽  
Long Acting

Abstract Background The COVID-19 pandemic has exerted a significant toll on the lives of people who use opioids (PWUOs). At the same time, more flexible regulations around provision of opioid use disorder (OUD) services have led to new opportunities for facilitating access to services for PWUOs. In the current scoping review, we describe new services and service modifications implemented by treatment and harm reduction programs serving PWUO, and discuss implications for policy and practice. Methods Literature searches were conducted within PubMed, LitCovid, Embase, and PsycInfo for English-language studies published in 2020 that describe a particular program, service, or intervention aimed at facilitating access to OUD treatment and/or harm reduction services during the COVID-19 pandemic. Abstracts were independently screened by two reviewers. Relevant studies were reviewed in full and those that met inclusion criteria underwent final data extraction and synthesis (n = 25). We used a narrative synthesis approach to identify major themes around key service modifications and innovations implemented across programs serving PWUO. Results Reviewed OUD treatment and harm reduction services spanned five continents and a range of settings from substance use treatment to street outreach programs. Innovative service modifications to adapt to COVID-19 circumstances primarily involved expanded use of telehealth services (e.g., telemedicine visits for buprenorphine, virtual individual or group therapy sessions, provision of donated or publicly available phones), increased take-home medication allowances for methadone and buprenorphine, expanded uptake of long-acting opioid medications (e.g. extended-release buprenorphine and naltrexone), home delivery of services (e.g. MOUD, naloxone and urine drug screening), outreach and makeshift services for delivering MOUD and naloxone, and provision of a safe supply of opioids. Conclusions The COVID-19 pandemic has posed multiple challenges for PWUOs, while simultaneously accelerating innovations in policies, care models, and technologies to lower thresholds for life-saving treatment and harm reduction services. Such innovations highlight novel patient-centered and feasible approaches to mitigating OUD related harms. Further studies are needed to assess the long-term impact of these approaches and inform policies that improve access to care for PWUOs.

Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4112-4112
Author(s):  
Jonathan R. Strosberg ◽  
Martyn E Caplin ◽  
Pamela L. Kunz ◽  
Philippe B Ruszniewski ◽  
Lisa Bodei ◽  
...  
Keyword(s):  
Overall Survival ◽  
Neuroendocrine Tumors ◽  
High Dose ◽  
Radioligand Therapy ◽  
Phase 3 ◽  
Long Term Follow Up ◽  
Long Acting ◽  
Safety Signals

4112 Background: As demonstrated in the primary analysis of the phase 3 NETTER-1 trial, 177Lu-DOTATATE significantly prolonged progression-free survival (PFS) versus high-dose long-acting octreotide, with a HR of 0.18 (95% CI: 0.11, 0.29; p < 0.0001), in patients with advanced, progressive, well-differentiated, somatostatin receptor-positive midgut neuroendocrine tumors (NETs). Here we report final overall survival (OS) for NETTER-1. Methods: In this international open-label trial, eligible patients were randomized to receive either four cycles of 177Lu-DOTATATE 7.4 GBq (200 mCi) every 8 ± 1 weeks plus long-acting octreotide 30 mg or high-dose long-acting octreotide 60 mg every 4 weeks (control arm), both on top of best supportive care. After disease progression on randomized treatment or completion of an 18-month treatment period, patients in both arms entered long-term follow-up and could receive further anti-cancer treatment as recommended by their physicians. The primary endpoint was PFS per RECIST 1.1 and OS was a key secondary endpoint. Primary intention-to-treat analysis of OS was prespecified to take place after 158 deaths or 5 years after the last patient was randomized, whichever occurred first. Results: Of 231 randomized patients, 101/117 (86.3%) in the 177Lu-DOTATATE arm and 99/114 (86.8%) in the control arm entered long-term follow-up. Final analysis occurred 5 years after the last patient was randomized, following 142 deaths, with a median follow-up of more than 76 months. During long-term follow-up, 41/114 (36%) of patients in the control arm received subsequent radioligand therapy (“cross-over”), the majority (22.8%) within 24 months. Median OS was 48.0 months (95% CI: 37.4, 55.2) in the 177Lu-DOTATATE arm and 36.3 months (95% CI: 25.9, 51.7) in the control arm. HR was 0.84 (95% CI: 0.60, 1.17) with p = 0.30 (unstratified 2-sided log-rank test). A total of 2/112 (1.8%) 177Lu-DOTATATE treated patients in the study developed myelodysplastic syndrome (MDS). No new cases of MDS or acute leukemia were reported in the long-term follow-up. Overall, no new safety signals emerged during long-term follow-up. Conclusions: Median OS was 48.0 months in the 177Lu-DOTATATE arm of the NETTER-1 trial and 36.3 months in the control arm. This difference was not statistically significant, potentially impacted by a high rate (36%) of cross-over of patients in the control arm to radioligand therapy after progression. In overall conclusion, the NETTER-1 study demonstrated that 177Lu-DOTATATE yielded a clinically and statistically significant improvement in PFS as a primary endpoint (HR: 0.18, p < 0.0001) as well as a clinically meaningful trend towards improvement in median OS of 11.7 months. No new safety signals emerged during the 5-year long-term follow-up. Clinical trial information: NCT01578239.

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