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1.
PLoS One ; 15(9): e0238618, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32915834

RESUMO

INTRODUCTION: British Columbia's (BC) Take-Home Naloxone (THN) program provides naloxone to bystanders for use in cases of suspected opioid overdose. This study seeks to provide trends and analysis from the provincial BC THN program since inception in 2012 to the end of 2018. MATERIALS AND METHODS: BC THN shipment and distribution records from 2012-2018 were retrieved. Frequency distributions were used to describe characteristics of individuals accessing the program. To evaluate correlates of distribution after the addition of hundreds of pharmacy distribution sites, an analytic sample was limited to records from 2018, and multivariate logistic regression was used to evaluate correlates of collecting naloxone at a pharmacy site. RESULTS: Since program inception to the end of 2018, there were 398,167 naloxone kits shipped to distribution sites, 149,999 kits reported distributed, and 40,903 kits reported used to reverse an overdose in BC. There was a significant increasing trend in the number of naloxone kits used to reverse an overdose over time (p<0.01), and more than 90% of kits that were reported used were distributed to persons at risk of an overdose. Individuals not personally at risk of overdose had higher odds of collecting naloxone at a pharmacy site, compared to other community sites (including harm reduction supply distribution sites, peer led organizations, drop-in centers, and supportive housing sites) (Adjusted Odds Ratio (AOR): 2.69; 95% CI: 2.50-2.90). CONCLUSIONS: This study documents thousands of opioid overdose reversals facilitated through the BC THN program. While those at highest risk of overdose may preferentially access naloxone through community sites, naloxone distribution through pharmacies has allowed the BC THN program to expand dramatically, increasing naloxone availability through longer opening hours on evenings and weekends. and in rural and remote regions. A diversity of naloxone distribution sites and strategies is crucial to prevent rising opioid overdose deaths.


Assuntos
Overdose de Drogas/tratamento farmacológico , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Adulto , Colúmbia Britânica/epidemiologia , Overdose de Drogas/epidemiologia , Overdose de Drogas/prevenção & controle , Feminino , Redução do Dano , Humanos , Masculino , Pessoa de Meia-Idade , Naloxona/efeitos adversos , Antagonistas de Entorpecentes/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Farmácias/tendências
4.
Med Care ; 58(10): 919-926, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32842044

RESUMO

BACKGROUND: Relative costs of care among treatment options for opioid use disorder (OUD) are unknown. METHODS: We identified a cohort of 40,885 individuals with a new diagnosis of OUD in a large national de-identified claims database covering commercially insured and Medicare Advantage enrollees. We assigned individuals to 1 of 6 mutually exclusive initial treatment pathways: (1) Inpatient Detox/Rehabilitation Treatment Center; (2) Behavioral Health Intensive, intensive outpatient or Partial Hospitalization Services; (3) Methadone or Buprenorphine; (4) Naltrexone; (5) Behavioral Health Outpatient Services, or; (6) No Treatment. We assessed total costs of care in the initial 90 day treatment period for each strategy using a differences in differences approach controlling for baseline costs. RESULTS: Within 90 days of diagnosis, 94.8% of individuals received treatment, with the initial treatments being: 15.8% for Inpatient Detox/Rehabilitation Treatment Center, 4.8% for Behavioral Health Intensive, Intensive Outpatient or Partial Hospitalization Services, 12.5% for buprenorphine/methadone, 2.4% for naltrexone, and 59.3% for Behavioral Health Outpatient Services. Average unadjusted costs increased from $3250 per member per month (SD $7846) at baseline to $5047 per member per month (SD $11,856) in the 90 day follow-up period. Compared with no treatment, initial 90 day costs were lower for buprenorphine/methadone [Adjusted Difference in Differences Cost Ratio (ADIDCR) 0.65; 95% confidence interval (CI), 0.52-0.80], naltrexone (ADIDCR 0.53; 95% CI, 0.42-0.67), and behavioral health outpatient (ADIDCR 0.54; 95% CI, 0.44-0.66). Costs were higher for inpatient detox (ADIDCR 2.30; 95% CI, 1.88-2.83). CONCLUSION: Improving health system capacity and insurance coverage and incentives for outpatient management of OUD may reduce health care costs.


Assuntos
Tratamento de Substituição de Opiáceos/economia , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/economia , Transtornos Relacionados ao Uso de Opioides/reabilitação , Adolescente , Adulto , Idoso , Assistência Ambulatorial/economia , Terapia Comportamental/economia , Buprenorfina/uso terapêutico , Estudos de Coortes , Feminino , Custos de Cuidados de Saúde , Hospitalização/economia , Humanos , Masculino , Medicare , Metadona/uso terapêutico , Pessoa de Meia-Idade , Naltrexona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Estudos Retrospectivos , Estados Unidos
7.
Acta Med Port ; 33(10): 693-702, 2020 Oct 01.
Artigo em Português | MEDLINE | ID: mdl-32705981

RESUMO

INTRODUCTION: The COVID-19 pandemic is a particularly relevant threat to mentally ill patients, and it constitutes a new challenge for health care providers. To the best of our knowledge, there is not any embracing published review about the use of psychotropic drugs during the COVID-19 pandemic. MATERIALS AND METHODS: Non-systematic literature review. A search in the PubMed database was performed, with the terms 'psychotropic drugs', 'COVID-19', 'psychiatry' and 'pandemic'. Consensus and clinical guidelines about psychotropic drugs and COVID-19 approach, published by scientific societies, governmental entities and drug regulatory agencies were included. RESULTS AND DISCUSSION: We present the recommendations about the use of psychotropic drugs during the COVID-19 pandemic, in the outpatient and inpatient settings. The treatment of affective bipolar disorder and schizophrenia have now added increased difficulties. Some psychotropic drugs interfere with the pathophysiology of the novel coronavirus infection and they could interact with the drugs used in the treatment of COVID-19. Some patients will need pharmacological interventions due to the presence of delirium. Smoking cessation changes the serum levels of some psychotropic drugs and may influence their use. CONCLUSION: The COVID-19 pandemic has created new challenges in clinical practice. Psychiatric patients are a vulnerable population and often a careful clinical, laboratorial and electrocardiographic evaluation may be needed, particularly in those diagnosed with COVID-19. The regular treatment of mentally ill patients with COVID-19 presents increased complexity.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Transtornos Mentais/tratamento farmacológico , Pneumonia Viral/epidemiologia , Psicotrópicos/uso terapêutico , Antivirais/uso terapêutico , Benzodiazepinas/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Regulação da Temperatura Corporal/efeitos dos fármacos , Regulação da Temperatura Corporal/fisiologia , Buprenorfina/efeitos adversos , Buprenorfina/uso terapêutico , Clozapina/uso terapêutico , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Preparações de Ação Retardada/uso terapêutico , Interações Medicamentosas , Hospitalização , Humanos , Compostos de Lítio/uso terapêutico , Transtornos Mentais/complicações , Metadona/efeitos adversos , Metadona/uso terapêutico , Antagonistas de Entorpecentes/efeitos adversos , Antagonistas de Entorpecentes/uso terapêutico , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/tratamento farmacológico , Esquizofrenia/tratamento farmacológico , Agentes de Cessação do Hábito de Fumar/uso terapêutico , Ácido Valproico/uso terapêutico
8.
Medicine (Baltimore) ; 99(22): e20033, 2020 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-32481373

RESUMO

Though overall death from opioid overdose are increasing in the United States, the death rate in some states and population groups is stabilizing or even decreasing. Several states have enacted a Naloxone Accessibility Laws to increase naloxone availability as an opioid antidote. The extent to which these laws permit layperson distribution and possession varies. The aim of this study is to investigate differences in provisions of Naloxone Accessibility Laws by states mainly in the Northeast and West regions, and the impact of naloxone availability on the rates of drug overdose deaths.This cross-sectional study was based on the National Vital Statistics System multiple cause-of-death mortality files. The average changes in drug overdose death rates between 2013 and 2017 in relevant states of the Northeast and West regions were compared according to availability of naloxone to laypersons.Seven states in the Northeast region and 10 states in the Western region allowed layperson distribution of naloxone. Layperson possession of naloxone was allowed in 3 states each in the Northeast and the Western regions. The average drug overdose death rates increased in many states in the both regions regardless of legalization of layperson naloxone distribution. The average death rates of 3 states that legalized layperson possession in the West region decreased (-0.33 per 100,000 person); however, in states in the West region that did not allow layperson possession and states in the Northeast region regardless of layperson possession increased between 2013 and 2017.The provision to legalize layperson possession of naloxone was associated with decreased average opioid overdose death rates in 3 states of the West region.


Assuntos
Analgésicos Opioides/envenenamento , Overdose de Drogas/mortalidade , Acesso aos Serviços de Saúde/legislação & jurisprudência , Naloxona/provisão & distribução , Antagonistas de Entorpecentes/provisão & distribução , Estudos Transversais , Overdose de Drogas/tratamento farmacológico , Acesso aos Serviços de Saúde/tendências , Humanos , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Estudos Retrospectivos , Governo Estadual , Estados Unidos
9.
Med Clin North Am ; 104(4): 695-708, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32505261

RESUMO

The diagnosis of opioid use disorder (OUD) is often overlooked or inadequately managed during the inpatient admission. When recognized, a common strategy is opioid detoxification, an approach that is often ineffective and can be potentially dangerous because of loss of tolerance and subsequent risk for overdose. Medication for addiction treatment (MAT), including methadone and buprenorphine, is effective and can be dispensed in the hospital for both opioid withdrawal and initiation of maintenance treatment. Hospitalists should be knowledgeable about diagnosing and managing patients with OUD, including how to manage acute pain or MAT during the perioperative setting.


Assuntos
Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/terapia , Educação de Pacientes como Assunto/métodos , Analgésicos Opioides/uso terapêutico , Buprenorfina/uso terapêutico , Redução do Dano , Hospitalização , Humanos , Metadona/uso terapêutico , Naltrexona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/psicologia
10.
JAMA ; 323(22): 2310-2328, 2020 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-32515820

RESUMO

Importance: Illicit drug use is among the most common causes of preventable morbidity and mortality in the US. Objective: To systematically review the literature on screening and interventions for drug use to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, PsycINFO, Embase, and Cochrane Central Register of Controlled Trials through September 18, 2018; literature surveillance through September 21, 2019. Study Selection: Test accuracy studies to detect drug misuse and randomized clinical trials of screening and interventions to reduce drug use. Data Extraction and Synthesis: Critical appraisal and data abstraction by 2 reviewers and random-effects meta-analyses. Main Outcomes and Measures: Sensitivity, specificity, drug use and other health, social, and legal outcomes. Results: Ninety-nine studies (N = 84 206) were included. Twenty-eight studies (n = 65 720) addressed drug screening accuracy. Among adults, sensitivity and specificity of screening tools for detecting unhealthy drug use ranged from 0.71 to 0.94 and 0.87 to 0.97, respectively. Interventions to reduce drug use were evaluated in 52 trials (n = 15 659) of psychosocial interventions, 7 trials (n = 1109) of opioid agonist therapy, and 13 trials (n = 1718) of naltrexone. Psychosocial interventions were associated with increased likelihood of drug use abstinence (15 trials, n = 3636; relative risk [RR], 1.60 [95% CI, 1.24 to 2.13]; absolute risk difference [ARD], 9% [95% CI, 5% to 15%]) and reduced number of drug use days (19 trials, n = 5085; mean difference, -0.49 day in the last 7 days [95% CI, -0.85 to -0.13]) vs no psychosocial intervention at 3- to 4-month follow-up. In treatment-seeking populations, opioid agonist therapy and naltrexone were associated with decreased risk of drug use relapse (4 trials, n = 567; RR, 0.75 [95% CI, 0.59 to 0.82]; ARD, -35% [95% CI, -67% to -3%] and 12 trials, n = 1599; RR, 0.73 [95% CI, 0.62 to 0.85]; ARD, -18% [95% CI, -26% to -10%], respectively) vs placebo or no medication. While evidence on harms was limited, it indicated no increased risk of serious adverse events. Conclusions and Relevance: Several screening instruments with acceptable sensitivity and specificity are available to screen for drug use, although there is no direct evidence on the benefits or harms of screening. Pharmacotherapy and psychosocial interventions are effective at improving drug use outcomes, but evidence of effectiveness remains primarily derived from trials conducted in treatment-seeking populations.


Assuntos
Programas de Rastreamento/normas , Antagonistas de Entorpecentes/uso terapêutico , Psicoterapia , Detecção do Abuso de Substâncias/normas , Transtornos Relacionados ao Uso de Substâncias/diagnóstico , Adolescente , Adulto , Feminino , Humanos , Programas de Rastreamento/efeitos adversos , Programas de Rastreamento/métodos , Naloxona/efeitos adversos , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/efeitos adversos , Guias de Prática Clínica como Assunto , Gravidez , Sensibilidade e Especificidade , Detecção do Abuso de Substâncias/métodos , Transtornos Relacionados ao Uso de Substâncias/tratamento farmacológico , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle , Transtornos Relacionados ao Uso de Substâncias/terapia , Inquéritos e Questionários
11.
JAMA ; 323(22): 2301-2309, 2020 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-32515821

RESUMO

Importance: An estimated 12% of adults 18 years or older and 8% of adolescents aged 12 to 17 years report unhealthy use of prescription or illegal drugs in the US. Objective: To update its 2008 recommendation, the USPSTF commissioned reviews of the evidence on screening by asking questions about drug use and interventions for unhealthy drug use in adults and adolescents. Population: This recommendation statement applies to adults 18 years or older, including pregnant and postpartum persons, and adolescents aged 12 to 17 years in primary care settings. This statement does not apply to adolescents or adults who have a currently diagnosed drug use disorder or are currently undergoing or have been referred for drug use treatment. This statement applies to settings and populations for which services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred. Evidence Assessment: In adults, the USPSTF concludes with moderate certainty that screening by asking questions about unhealthy drug use has moderate net benefit when services for accurate diagnosis of unhealthy drug use or drug use disorders, effective treatment, and appropriate care can be offered or referred. In adolescents, because of the lack of evidence, the USPSTF concludes that the benefits and harms of screening for unhealthy drug use are uncertain and that the balance of benefits and harms cannot be determined. Recommendation: The USPSTF recommends screening by asking questions about unhealthy drug use in adults 18 years or older. Screening should be implemented when services for accurate diagnosis, effective treatment, and appropriate care can be offered or referred. (Screening refers to asking questions about unhealthy drug use, not testing biological specimens.) (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for unhealthy drug use in adolescents. (I statement).


Assuntos
Programas de Rastreamento/normas , Antagonistas de Entorpecentes/uso terapêutico , Psicoterapia , Detecção do Abuso de Substâncias/normas , Transtornos Relacionados ao Uso de Substâncias/diagnóstico , Adolescente , Adulto , Humanos , Programas de Rastreamento/efeitos adversos , Programas de Rastreamento/métodos , Antagonistas de Entorpecentes/efeitos adversos , Sensibilidade e Especificidade , Detecção do Abuso de Substâncias/métodos , Transtornos Relacionados ao Uso de Substâncias/tratamento farmacológico , Transtornos Relacionados ao Uso de Substâncias/terapia , Inquéritos e Questionários
12.
J Addict Med ; 14(4): e8-e9, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32404652

RESUMO

: During the COVID-19 pandemic, many addiction treatment and harm reduction organizations have had to reduce their hours and services for people with substance use disorders, placing these individuals at increased risk of death. In order to address restricted treatment access during COVID-19, guidance from the Substance Abuse Mental Health Services Administration, the US Drug Enforcement Administration, and the US Department of Health and Human Services has allowed for use of audio-only telehealth encounters for buprenorphine induction without requiring an in-person evaluation or video interface. This has enabled innovations in order to try to meet the needs of the most vulnerable among us during the current pandemic. In this new regulatory environment, we established the Rhode Island Buprenorphine Hotline, a phone hotline which functions as a "tele-bridge" clinic where people with moderate to severe opioid use disorder can be linked with a DATA 2000 waivered provider who can provide an initial assessment and, if appropriate, prescribe buprenorphine for unobserved induction and linkage to outpatient treatment. In this correspondence we briefly share our experience developing this common sense approach to addressing the complex problem of access to treatment only now permissible due to regulatory changes during COVID-19.


Assuntos
Infecções por Coronavirus , Acesso aos Serviços de Saúde/organização & administração , Controle de Infecções/organização & administração , Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides , Pandemias , Pneumonia Viral , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/psicologia , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Telemedicina/métodos , Telemedicina/organização & administração , Estados Unidos
13.
J Addict Med ; 14(4): e1-e3, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32412931

RESUMO

: The COVID-19 health crisis joined, rather than supplanted, the opioid crisis as the most acutely pressing threats to US public health. In the setting of COVID-19, opioid use disorder treatment paradigms are being disrupted, including the fact that methadone clinics are scrambling to give "take-home" doses where they would typically not. The rapid transition away from in-person examination, dosing and group therapy in an era of social isolation calls for adjustments to clinical practice, including emphasizing patient-provider communication, favoring new inductees on buprenorphine and leveraging technology to optimize safety of medication treatment.


Assuntos
Infecções por Coronavirus , Controle de Infecções/organização & administração , Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides , Pandemias , Pneumonia Viral , Centros de Tratamento de Abuso de Substâncias , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/psicologia , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Saúde Pública , Centros de Tratamento de Abuso de Substâncias/métodos , Centros de Tratamento de Abuso de Substâncias/organização & administração , Centros de Tratamento de Abuso de Substâncias/tendências , Estados Unidos/epidemiologia
14.
N Engl J Med ; 382(22): 2129-2136, 2020 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-32459923

RESUMO

BACKGROUND: The opioid crisis highlights the need to increase access to naloxone, possibly through regulatory approval for over-the-counter sales. To address industry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales to assess whether consumers understood the key statements for safe and effective use. METHODS: In this label-comprehension study, we conducted individual structured interviews with 710 adults and adolescents, including 430 adults who use opioids and their family and friends. Eight primary end points were developed to assess user comprehension of each of the key steps in the label. Each of these end points included a prespecified target threshold ranging from 80 to 90% that was evaluated through a comparison of the lower boundary of the 95% exact confidence interval. RESULTS: The results for performance on six primary end points met or exceeded thresholds, including the steps "Check for a suspected overdose" (threshold, 85%; point estimate [PE], 95.8%; 95% confidence interval [CI], 94.0 to 97.1) and "Give the first dose" (threshold, 85%; PE, 98.2%; 95% CI, 96.9 to 99.0). The lower boundaries for four other primary end points ranged from 88.8 to 94.0%. One exception was comprehension of "Call 911 immediately," but this instruction closely approximated the target of 90% (PE, 90.3%; 95% CI, 87.9 to 92.4). Another exception was comprehension of the composite step of "Check, give, and call 911 immediately" (threshold, 85%; PE, 81.1%; 95% CI, 78.0 to 83.9). CONCLUSIONS: Consumers met thresholds for sufficient understanding of six of eight components of the instructions in the drug facts label for naloxone use and came close on two others. Overall, the FDA found that the model label was adequate for use in the development of a naloxone product intended for over-the-counter sales.


Assuntos
Analgésicos Opioides/envenenamento , Compreensão , Rotulagem de Medicamentos , Overdose de Drogas/tratamento farmacológico , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Medicamentos sem Prescrição/uso terapêutico , Adolescente , Adulto , Rotulagem de Medicamentos/legislação & jurisprudência , Overdose de Drogas/terapia , Regulamentação Governamental , Humanos , Entrevistas como Assunto , Estados Unidos , United States Food and Drug Administration
17.
Aliment Pharmacol Ther ; 52(1): 37-53, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32462777

RESUMO

BACKGROUND: When opioid-induced constipation is treated with centrally acting opioid antagonists, there may be opioid withdrawal or aggravation of pain due to inhibition of µ-opioid analgesia. This led to the development of peripherally acting µ-opioid receptor antagonists (PAMORAs). AIM: To evaluate the efficacy of available PAMORAs and other approved or experimental treatments for relieving constipation in patients with opioid-induced constipation, based on a systematic review and meta-analysis of published studies. METHODS: A search of MEDLINE, EMBASE and EBM Reviews Cochrane Central Register of Controlled Trials was completed in July 2019 for randomised trials compared to placebo. FDA approved doses or highest studied dose was evaluated. Efficacy was based on diverse endpoints, including continuous variables (the bowel function index, number of spontaneous bowel movements and stool consistency based on Bristol Stool Form Scale), or responder analysis (combination of >3 spontaneous bowel movements or complete spontaneous bowel movements plus 1 spontaneous bowel movement or complete spontaneous bowel movements, respectively, over baseline [so-called FDA endpoints]). Adverse effects evaluated included central opioid withdrawal, serious adverse events, abdominal pain and diarrhoea. RESULTS: We included 35 trials at low risk of bias enrolling 13 566 patients. All PAMORAs demonstrated efficacy on diverse patient response endpoints. There was greater efficacy with approved doses of the PAMORAs (methylnaltrexone, naloxegol and naldemidine), with lower efficacy or lower efficacy and greater adverse effects with combination oxycodone with naloxone, lubiprostone and linaclotide. CONCLUSIONS: Therapeutic response in opioid-induced constipation is best achieved with the PAMORAs, methylnaltrexone, naloxegol and naldemidine, which are associated with low risk of serious adverse events.


Assuntos
Analgésicos Opioides/efeitos adversos , Constipação Intestinal/tratamento farmacológico , Laxantes/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Receptores Opioides mu/antagonistas & inibidores , Constipação Intestinal/induzido quimicamente , Humanos , Laxantes/efeitos adversos , Antagonistas de Entorpecentes/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
18.
J Addict Med ; 14(4): e6-e7, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32404651

RESUMO

: The COVID19 crisis has created many additional challenges for patients with opioid use disorder, including those seeking treatment with medications for OUD. Some of these challenges include closure of substance use treatment clinics, focus of emergency departments on COVID-19 patients, social distancing and shelter in place orders affecting mental health, bystander overdose rescue, threats to income and supply of substances for people who use drugs. While the initial changes in regulation allowing buprenorphine prescribing by telehealth are welcomed by providers and patients, many additional innovations are required to ensure that additional vulnerabilities and hurdles created by this pandemic scenario do not further fan the flames of the opioid epidemic.


Assuntos
Infecções por Coronavirus , Acesso aos Serviços de Saúde/organização & administração , Controle de Infecções/organização & administração , Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides , Pandemias , Pneumonia Viral , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/psicologia , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Telemedicina/organização & administração , Estados Unidos
19.
Nat Med ; 26(5): 760-768, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32231295

RESUMO

The National Institute of Mental Health (NIMH) 'fast-fail' approach seeks to improve too-often-misleading early-phase drug development methods by incorporating biomarker-based proof-of-mechanism (POM) testing in phase 2a. This first comprehensive application of the fast-fail approach evaluated the potential of κ-opioid receptor (KOR) antagonism for treating anhedonia with a POM study determining whether robust target engagement favorably impacts the brain circuitry hypothesized to mediate clinical effects. Here we report the results from a multicenter, 8-week, double-blind, placebo-controlled, randomized trial in patients with anhedonia and a mood or anxiety disorder (selective KOR antagonist (JNJ-67953964, 10 mg; n = 45) and placebo (n = 44)). JNJ-67953964 significantly increased functional magnetic resonance imaging (fMRI) ventral striatum activation during reward anticipation (primary outcome) as compared to placebo (baseline-adjusted mean: JNJ-67953964, 0.72 (s.d. = 0.67); placebo, 0.33 (s.d. = 0.68); F(1,86) = 5.58, P < 0.01; effect size = 0.58 (95% confidence interval, 0.13-0.99)). JNJ-67953964, generally well tolerated, was not associated with any serious adverse events. This study supports proceeding with assessment of the clinical impact of target engagement and serves as a model for implementing the 'fast-fail' approach.


Assuntos
Anedonia/efeitos dos fármacos , Benzamidas/uso terapêutico , Transtornos do Humor/tratamento farmacológico , Antagonistas de Entorpecentes/uso terapêutico , Pirrolidinas/uso terapêutico , Receptores Opioides kappa/antagonistas & inibidores , Adulto , Transtornos de Ansiedade/complicações , Transtornos de Ansiedade/tratamento farmacológico , Transtornos de Ansiedade/psicologia , Fármacos do Sistema Nervoso Central/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos do Humor/complicações , Transtornos do Humor/psicologia , Estudo de Prova de Conceito , Fatores de Tempo , Resultado do Tratamento
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