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OBJECTIVES: This study investigates the impact of participation in self-help groups on treatment completion among individuals undergoing medication for opioid use disorder (MOUD) treatment. Given the suboptimal adherence and retention rates for MOUD, this research seeks to examine the association between treatment completion and patient-level factors. Specifically, we evaluated the causal relationship between self-help group participation and treatment completion for patients undergoing MOUD. METHODS: We used the Substance Abuse and Mental Health Services Administration's (SAMHSA) Treatment Episode Data Set: Discharges (TEDS-D) from 2015 to 2019. The data are filtered by the patient's opioid use history, demographics, treatment modality, and other relevant information. In this observational study, machine learning models (Lasso Regression, Decision Trees, Random Forest, and XGBoost) were developed to predict treatment completion. Outcome Adaptive Elastic Net (OAENet) was used to select confounders and outcome predictors, and the robust McNemars test was used to evaluate the causal relationship between self-help group participation and MOUD treatment completion. RESULTS: The machine-learning models showed a strong association between participation in self-help groups and treatment completion. Our causal analysis demonstrated an average treatment effect on treated (ATT) of 0.260 and a p-value < 0.0001 for the robust McNemars test. CONCLUSIONS: Our study demonstrates the importance of participation in self-help groups for MOUD treatment recipients. We found that participation in MOUD along with self-help groups caused higher chances of treatment completion than MOUD alone. This suggests that policymakers should consider further integrating self-help groups into the treatment for OUD to improve the adherence and completion rate.
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INTRODUCTION: Telehealth-only provision of buprenorphine for the treatment of opioid use disorder (OUD) was first made possible during the COVID-19 pandemic. However, Alabama instituted a law in July 2022 that mandated an annual in-person visit in order to receive this treatment. In July 2023, our usually telehealth-only group established a temporary clinic in Birmingham to meet this requirement. METHODS: The study administered a survey instrument to patients at the time of clinic check-in. RESULTS: 158 of 160 (98.8 %) patients completed the survey. Mean distance traveled was 86.4 (standard deviation (SD) 53.7) miles; time required for travel was mean 1.6 (SD 1.0) hours. Twenty-five patients (15.8 %) reported needing to find childcare to attend the visit and 40 patients (25.3 %) reported missing work to attend. Patients disagreed (median 2 on 1-5 Likert scale, interquartile range (IQR) <1-3>) that it is important to see their provider in-person, that seeing their provider in-person improves care or improves their ability to succeed in treatment, and that they have other OUD treatment resources in their community. Patients strongly agreed (median 5, IQR <5-5>) that OUD can be treated by telehealth without the need for an in-person visit. CONCLUSIONS: An annual in-person visits requirement to receive telehealth OUD services imposed a significant burden on patients, was not desired by patients, and may be associated with harm.
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Importance: Hospitalizations related to opioid use disorder (OUD) represent an opportunity to initiate medication for OUD (MOUD). Objective: To assess whether starting MOUD after a hospitalization or emergency department (ED) visit is associated with the odds of fatal and nonfatal opioid overdose at 6 and 12 months. Design, Setting, and Participants: This population-based cohort study used data from the Oregon Comprehensive Opioid Risk Registry, which links all payer claims data to other administrative health datasets, for individuals aged 18 years or older who had diagnosis codes related to OUD recorded at an index ED visit or hospitalization from January 2017 to December 2019. Data were analyzed between May 2023 and January 2024. Exposures: Receipt of MOUD within the 7 days after an OUD-related hospital visit. Main Outcomes and Measures: The primary outcome was fatal or nonfatal overdose at 6 and 12 months after discharge. Sample characteristics, including age, sex, insurance plan, number of comorbidities, and opioid-related overdose events, were stratified by receipt or nonreceipt of MOUD within 7 days after an OUD-related hospital visit. A logistic regression model was used to investigate the association between receipt of MOUD and having an opioid overdose event. Results: The study included 22â¯235 patients (53.1% female; 25.0% aged 25-39 years) who had an OUD-related hospital visit during the study period. Overall, 1184 patients (5.3%) received MOUD within 7 days of their ED visit or hospitalization. Of these patients, 683 (57.7%) received buprenorphine, 463 (39.1%) received methadone, and 46 (3.9%) received long-acting injectable naltrexone. Patients who received MOUD within 7 days after discharge had lower adjusted odds of fatal or nonfatal overdose at 6 months compared with those who did not (adjusted odds ratio [AOR], 0.63; 95% CI, 0.41-0.97). At 12 months, there was no difference in adjusted odds of fatal or nonfatal overdose between these groups (AOR, 0.79; 95% CI, 0.58-1.08). Patients had a lower risk of fatal or nonfatal overdose at 6 months associated with buprenorphine use (AOR, 0.50; 95% CI, 0.27-0.95) but not with methadone use (AOR, 0.57; 95% CI, 0.28-1.17). Conclusions and Relevance: In this cohort study of individuals with an OUD-related hospital visit, initiation of MOUD was associated with reduced odds of opioid-related overdose at 6 months. Hospitals should consider implementing programs and protocols to offer initiation of MOUD to patients with OUD who present for care.
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Buprenorfina , Serviço Hospitalar de Emergência , Hospitalização , Overdose de Opiáceos , Transtornos Relacionados ao Uso de Opioides , Humanos , Masculino , Feminino , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Adulto , Hospitalização/estatística & dados numéricos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Overdose de Opiáceos/tratamento farmacológico , Overdose de Opiáceos/epidemiologia , Pessoa de Meia-Idade , Buprenorfina/uso terapêutico , Oregon , Estudos de Coortes , Analgésicos Opioides/uso terapêutico , Tratamento de Substituição de Opiáceos/estatística & dados numéricos , Tratamento de Substituição de Opiáceos/métodos , Adulto Jovem , Metadona/uso terapêutico , AdolescenteRESUMO
Background: It is unknown how many people in treatment for opioid use disorder (OUD) have naloxone, use naloxone, and what their perceptions and barriers to obtaining it are. Methods: This was a survey of patients treated in a large telehealth OUD program. Between December 6, 2023 and January 6, 2024, all patients who had access to the program's phone app (n=17,899 individuals, of whom 12,887 were in active treatment), were invited to complete an anonymous online survey. Results: There were 701 individuals who completed the survey. Nearly all patients (n=693, 99%) knew what naloxone is, and the majority (n=601, 86%) knew how to administer it. A quarter of these patients (n=177, 25%) reported either having naloxone used on themselves or using it on someone else. 161 patients (23%) reported taking a naloxone training course. Of patients who recalled receiving a prescription, 72% (n=382) filled the prescription, and 85% (n=321) reported that insurance paid for all or part of it. If filled, the naloxone was reported as used by 30 (8%) patients. If not filled, reasons were: already had it (n=55, 37%), did not think it was needed (n=54, 37%) or too expensive (n=36, 23%). Patients who reported knowing how to administer naloxone (OR 2.63 (95% CI 1.35-5.00) were more likely to fill the prescription. Conclusions: Patients prescribed naloxone in a telehealth treatment program filled the prescription 72% of the time, and when it was filled, 8% used the naloxone. Education and cost policy changes may reduce barriers to obtaining naloxone.
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BACKGROUND: For many emergency physicians (EPs), deciding whether or not to allow a patient suffering the ill effects of opioid use to refuse care is the most frequent and fraught situation in which they encounter issues of decision-making capacity, informed refusal, and autonomy. Despite the frequency of this issue and the well-known impacts of opioid use disorder on decision-making, the medical ethics community has offered little targeted analysis or guidance regarding these situations. DISCUSSION: As a result, EPs demonstrate significant variability in how they evaluate and respond to them, with highly divergent understandings and application of concepts such as decision-making capacity, informed consent, autonomy, legal repercussions, and strategies to resolve the clinical dilemma. In this paper, we seek to provide more clarity to this issue for the EPs. CONCLUSIONS: Successfully navigating this issue requires that EPs understand the specific effects that opioid use disorder has on decision-making, and how that in turn bears on the ethical concepts of autonomy, capacity, and informed refusal. Understanding these concepts can lead to helpful strategies to resolve these commonly-encountered dilemmas.
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Tomada de Decisões , Transtornos Relacionados ao Uso de Opioides , Recusa do Paciente ao Tratamento , Humanos , Transtornos Relacionados ao Uso de Opioides/psicologia , Recusa do Paciente ao Tratamento/psicologia , Tomada de Decisões/ética , Consentimento Livre e Esclarecido , Autonomia Pessoal , Cooperação do Paciente/psicologia , Analgésicos Opioides/uso terapêuticoRESUMO
This scoping review summarized the literature regarding naloxone distribution from emergency departments (EDs) without a prescription. Our intention was to examine various naloxone distribution programs, their methodologies, and the level of effectiveness of each. Understanding these key aspects of naloxone distribution could lead to improved standardized protocols, saving countless additional lives from opioid overdose. This review evaluated studies reporting naloxone distribution from EDs in the United States. The included studies were written in English and published between January 1, 2017, and December 31, 2022. Searches were performed using PubMed and Embase. A total of 129 studies were reviewed, with only 12 meeting the necessary criteria for analysis. Heterogeneity was found across naloxone distribution programs, including how patients were identified, how naloxone was dispensed to patients, and the specific naloxone products made available. The protocols included various methods, such as patient screening, where information used for this screening was sometimes obtained from health records or patient interviews. Some programs detailed only the distribution of naloxone, while others included additional interventions such as behavior counseling, peer support, and education. In four studies, patients received buprenorphine with naloxone kits. The various programs differed in their implementation but were generally successful in improving naloxone distribution. However, among the studies reviewed, the percentage of ED patients receiving naloxone varied from â¼30% to 70%, suggesting that certain program elements may be more impactful. Further research is needed to identify key elements of the most impactful programs in order to improve naloxone distribution and improve patient odds of surviving an opioid overdose.
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Introduction: Bystander provision of naloxone is a key modality to reduce opioid overdose-related death. Naloxone training courses are available, but no standardized program exists. As part of a bystander empowerment course, we created and evaluated a brief naloxone training module. Methods: This was a retrospective evaluation of a naloxone training course, which was paired with Stop the Bleed training for hemorrhage control and was offered to administrative staff in an office building. Participants worked in an organization related to healthcare, but none were clinicians. The curriculum included the following topics: 1) background about the opioid epidemic; 2) how to recognize the signs of an opioid overdose; 3) actions not to take when encountering an overdose victim; 4) the correct steps to take when encountering an overdose victim; 5) an overview of naloxone products; and 6) Good Samaritan protection laws. The 20-minute didactic section was followed by a hands-on session with nasal naloxone kits and a simulation mannequin. The course was evaluated with the Opioid Overdose Knowledge (OOKS) and Opioid Overdose Attitudes (OOAS) scales for take-home naloxone training evaluation. We used the paired Wilcoxon signed-rank test to compare scores pre- and post-course. Results: Twenty-eight participants completed the course. The OOKS, measuring objective knowledge about opioid overdose and naloxone, had improved scores from a median of 73.2% (interquartile range [IQR] 68.3%-79.9%) to 91.5% (IQR 85.4%-95.1%), P < 0.001. The three domains on the OOAS score also showed statistically significant results. Competency to manage an overdose improved on a five-point scale from a median of 2.5 (IQR 2.4-2.9) to a median of 3.7 (IQR 3.5-4.1), P < 0.001. Concerns about managing an overdose decreased (improved) from a median of 2.3 (IQR 1.9-2.6) to median 1.8 (IQR 1.5-2.1), P < 0.001. Readiness to intervene in an opioid overdose improved from a median of 4 (IQR 3.8-4.2) to a median of 4.2 (IQR 4-4.2), P < 0.001. Conclusion: A brief course designed to teach bystanders about opioid overdose and naloxone was feasible and effective. We encourage hospitals and other organizations to use and promulgate this model. Furthermore, we suggest the convening of a national consortium to achieve consensus on program content and delivery.
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Naloxona , Antagonistas de Entorpecentes , Naloxona/uso terapêutico , Humanos , Antagonistas de Entorpecentes/uso terapêutico , Estudos Retrospectivos , Masculino , Feminino , Overdose de Drogas/prevenção & controle , Overdose de Drogas/tratamento farmacológico , Overdose de Opiáceos/prevenção & controle , Adulto , Avaliação de Programas e Projetos de Saúde , Currículo , Conhecimentos, Atitudes e Prática em Saúde , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Telehealth-only medication for opioid use disorder (teleMOUD) treatment with buprenorphine was first made possible in the United States during the COVID-19 Public Health Emergency. As a result, several large provider groups now treat opioid use disorder (OUD) patients in nearly every state using telehealth. This study evaluates the perceptions and experiences of providers working almost exclusively in a teleMOUD program. METHODS: Qualitative interviews were conducted with 18 providers (physicians, physician assistants and nurse practitioners) using a semi-structured interview guide. Interviews were recorded, transcribed and reviewed. After reviewing the transcripts, a codebook was developed, interviews were coded, and coded excerpts were analyzed for key themes. RESULTS: Inductive codes were used to organize provider responses and included patient-level codes, provider-level codes, and telehealth environment codes. For providers, there are benefits of a flexible and less stressful working environment, which contribute to a higher quality of life. Providers also expressed mixed feelings regarding professional identity and focusing specifically on OUD, differences in relationships with colleagues, and challenges related to policy changes and ambiguities. For patients, providers perceived greater access, less stigma, more convenience, and a unique provider-patient relationship compared to in-person treatment. These themes affect providers and patients on multiple levels of the social-ecological model. CONCLUSIONS: Multiple themes emerged in this study. This work is amongst the first to describe perspectives of providers working in the nascent teleMOUD setting, and can inform initiatives to improve provider wellness, provider retention, and quality of care for patients treated in the setting.
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Transtornos Relacionados ao Uso de Opioides , Telemedicina , Humanos , Qualidade de Vida , Pesquisa Qualitativa , Afeto , Transtornos Relacionados ao Uso de Opioides/terapiaRESUMO
OBJECTIVES: Emergency departments (EDs) are a critical point of entry into treatment for patients struggling with opioid use disorder (OUD). When initiated in the ED, buprenorphine is associated with increased addiction treatment engagement at 30 days when initiated. Despite this association, it has had slow adoption. The barriers to ED buprenorphine utilization are well documented; however, the benefits of prescribing buprenorphine for emergency physicians (EPs) have not been explored. This study utilized semistructured interviews to explore and understand how EPs perceive their experiences working in EDs that have successfully implemented ED bridge programs (EDBPs) for patients with OUD. METHODS: Semistructured interviews were conducted with EPs from four geographically diverse academic hospitals with established EDBPs. Interviews were recorded and transcribed, and emergent themes were identified using codebook thematic analysis. Analysis credibility and transparency were confirmed with peer debriefing. RESULTS: Twenty-two interviews were conducted across the four sites. Three key themes were constructed during the analyses: (1) provided EPs agency; (2) transformed EPs' emotions, attitudes, and behaviors related to treating patients with OUD; and (3) improved EPs' professional quality of life. CONCLUSIONS: Participants in this study reported several common themes related to participation in their hospital's BP. Overall our results suggest that physicians who participate in EDBPs may feel a renewed sense of fulfillment and purpose in their personal and professional lives. These positive changes may lead to increased job satisfaction in hospitals that have successfully launched EDBP.
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Buprenorfina , Serviço Hospitalar de Emergência , Tratamento de Substituição de Opiáceos , Transtornos Relacionados ao Uso de Opioides , Pesquisa Qualitativa , Humanos , Buprenorfina/uso terapêutico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Masculino , Feminino , Tratamento de Substituição de Opiáceos/métodos , Adulto , Entrevistas como Assunto , Médicos/psicologia , Atitude do Pessoal de Saúde , Antagonistas de Entorpecentes/uso terapêutico , Pessoa de Meia-Idade , Medicina de EmergênciaRESUMO
OBJECTIVES: Telehealth treatment with medication for opioid use disorder (teleMOUD) was made possible with regulations following the COVID-19 pandemic that permitted prescribing buprenorphine without an in-person visit. This study evaluates the self-reported outcomes of patients treated by teleMOUD using the Brief Addiction Monitor (BAM), a 17-question tool that assesses drug use, cravings, physical and psychological health, and psychosocial factors to produce 3 subset scores: substance use, risk factors, and protective factors. METHODS: Patients treated by a teleMOUD provider group operating in >30 states were asked to complete an app-based version of BAM at enrollment and at 1 month. Patients who completed both assessments between June 2022 and March 2023 were included. RESULTS: A total of 2556 patients completed an enrollment BAM and 1447 completed both assessments. Mean number of days from baseline BAM to follow-up was 26.7 days. Changes were significantly different across most questions. The substance use subscale decreased from mean 2.6 to 0.8 (P < .001), the risk factors subscale decreased from mean 10.3 to 7.5 (P < .001), and the protective factors subscale increased from mean 14.3 to 15.0. (P < .001). Substance use and risk factor subscale changes were significant across all sex and age groups, while protective factors subscale did not improve for those <25 and >54 years. Patient reports of at least 1 day of illegal use or misuse decreased, including marijuana (28.1% vs 9.0%), cocaine/crack (3.9% vs 2.6%), and opioids (49.8% vs 10.5%). CONCLUSIONS: Among patients treated by teleMOUD who completed assessments at enrollment and 1 month, there was improvement in drug use, risk factor, and protective factor scores.
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Comportamento Aditivo , Transtornos Relacionados ao Uso de Opioides , Telemedicina , Humanos , Pessoa de Meia-Idade , Pandemias , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Analgésicos Opioides/efeitos adversosRESUMO
The American College of Emergency Physicians (ACEP) Emergency Medicine Quality Network (E-QUAL) Opioid Initiative was launched in 2018 to advance the dissemination of evidence-based resources to promote the care of emergency department (ED) patients with opioid use disorder. This virtual platform-based national learning collaborative includes a low-burden, structured quality improvement project, data benchmarking, tailored educational content, and resources designed to support a nationwide network of EDs with limited administrative and research infrastructure. As a part of this collaboration, we convened a group of experts to identify and design a set of measures to improve opioid prescribing practices to provide safe analgesia while reducing opioid-related harms. We present those measures here, alongside initial performance data on those measures from a sample of 370 nationwide community EDs participating in the 2019 E-QUAL collaborative. Measures include proportion of opioid administration in the ED, proportion of alternatives to opioids as first-line treatment, proportion of opioid prescription, opioid pill count per prescription, and patient medication safety education among ED visits for atraumatic back pain, dental pain, or headache. The proportion of benzodiazepine and opioid coprescribing for ED visits for atraumatic back pain was also evaluated. This project developed and effectively implemented a collection of 6 potential measures to evaluate opioid analgesic prescribing across a national sample of community EDs, representing the first feasibility assessment of opioid prescribing-related measures from rural and community EDs.
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Analgésicos Opioides , Indicadores de Qualidade em Assistência à Saúde , Humanos , Analgésicos Opioides/uso terapêutico , Padrões de Prática Médica , Serviço Hospitalar de Emergência , Dor nas CostasRESUMO
Physicians generally recommend that patients resuscitated with naloxone after opioid overdose stay in the emergency department for a period of observation in order to prevent harm from delayed sequelae of opioid toxicity. Patients frequently refuse this period of observation despiteenefit to risk. Healthcare providers are thus confronted with the challenge of how best to protect the patient's interests while also respecting autonomy, including assessing whether the patient is making an autonomous choice to refuse care. Previous studies have shown that physicians have widely divergent approaches to navigating these conflicts. This paper reviews what is known about the effects of opioid use disorder on decision-making, and argues that some subset of these refusals are non-autonomous choices, even when patients appear to have decision making capacity. This conclusion has several implications for how physicians assess and respond to patients refusing medical recommendations after naloxone resuscitation.
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Overdose de Opiáceos , Transtornos Relacionados ao Uso de Opioides , Humanos , Naloxona , Analgésicos Opioides , Recusa do Paciente ao TratamentoRESUMO
BACKGROUND: Poppy seed tea (PST) is a legally obtainable source of opiates made from the seeds of the opium poppy. Our large telehealth opioid use disorder (OUD) provider group has treated several patients with PST misuse. METHODS: We retrospectively identified patients with primary PST use disorder treated with buprenorphine in a telehealth-only practice with first visits between January 2021 and December 2022. Patients were identified by having the word "poppy" in their enrollment note, and then charts were reviewed to determine which patients had primary PST misuse. Demographics, buprenorphine doses, and retention in treatment were recorded. RESULTS: We identified 18 patients treated for PST use disorder. Fifteen (83.3%) identified as male, mean age was 40.4 (standard deviation 8.8) years, and patients resided in 10 different U.S. states. Median starting buprenorphine dose was 2 mg (interquartile range (IQR) 2-2.5 mg). Median stabilizing dose of buprenorphine was 16 mg daily (IQR 15-20.5 mg). As of June 2023, 5 patients (27.8%) were still in active treatment. Two patients (11.1%) had completed a planned, elective taper. Ten patients (55.6%) had unplanned discontinuation from treatment, and 3 patients (16.7%) discontinued for other reasons. CONCLUSIONS: To our knowledge, this is the largest case series describing PST misuse in the U.S., and the first to demonstrate its treatment in the telehealth setting. PST use disorder is treatable with buprenorphine with doses similar to treatment of other opioid use disorders. Clinicians who treat patients with OUD should be aware of PST use disorder and its treatment.
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BACKGROUND: This study aims to assess the association of community social vulnerability and community prescription opioid availability with individual non-fatal or fatal opioid overdose. METHODS: We identified patients 12 years of age or older from the Oregon All Payer Claims database (APCD) linked to other public health datasets. Community-level characteristics were captured in an exposure period (EP) (1/1/2018-12/31/2018) and included: census tract-level social vulnerability domains (socio-economic status, household composition, racial and ethnic minority status, and housing type and transportation), census tract-level prescriptions and community-level opioid use disorder (OUD) diagnoses per 100 capita binned into quartiles or quintiles. We employed Cox models to estimate the risk of fatal and non-fatal opioid overdoses events in the 12 months following the EP. MAIN FINDINGS: We identified 1,548,252 individuals. Patients were mostly female (54%), White (61%), commercially insured (54%), and lived in metropolitan areas (81%). Of the total sample, 2485 (0.2%) experienced a non-fatal opioid overdose and 297 died of opioid overdose. There was higher hazard for non-fatal overdose in communities with greater OUD per 100 capita. We also found higher non-fatal and fatal hazards for opioid overdose among patients in communities with higher housing type and transportation-related vulnerability compared to the lowest quintile. Conversely, patients were at less risk of opioid overdose when living in communities with greater prevalence of the young or the elderly, the disabled, single parent families or low English proficiency. CONCLUSION: These findings underscore the importance of the environmental context when considering public health policies to reduce opioid harms.
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Overdose de Drogas , Overdose de Opiáceos , Transtornos Relacionados ao Uso de Opioides , Humanos , Feminino , Idoso , Masculino , Analgésicos Opioides/uso terapêutico , Overdose de Opiáceos/epidemiologia , Overdose de Opiáceos/tratamento farmacológico , Etnicidade , Vulnerabilidade Social , Grupos Minoritários , Overdose de Drogas/epidemiologia , Overdose de Drogas/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , PrescriçõesRESUMO
BACKGROUND: The NaV1.8 voltage-gated sodium channel, expressed in peripheral nociceptive neurons, plays a role in transmitting nociceptive signals. The effect of VX-548, an oral, highly selective inhibitor of NaV1.8, on control of acute pain is being studied. METHODS: After establishing the selectivity of VX-548 for NaV1.8 inhibition in vitro, we conducted two phase 2 trials involving participants with acute pain after abdominoplasty or bunionectomy. In the abdominoplasty trial, participants were randomly assigned in a 1:1:1:1 ratio to receive one of the following over a 48-hour period: a 100-mg oral loading dose of VX-548, followed by a 50-mg maintenance dose every 12 hours (the high-dose group); a 60-mg loading dose of VX-548, followed by a 30-mg maintenance dose every 12 hours (the middle-dose group); hydrocodone bitartrate-acetaminophen (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen every 6 hours); or oral placebo every 6 hours. In the bunionectomy trial, participants were randomly assigned in a 2:2:1:2:2 ratio to receive one of the following over a 48-hour treatment period: oral high-dose VX-548; middle-dose VX-548; low-dose VX-548 (a 20-mg loading dose, followed by a 10-mg maintenance dose every 12 hours); oral hydrocodone bitartrate-acetaminophen (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen every 6 hours); or oral placebo every 6 hours. The primary end point was the time-weighted sum of the pain-intensity difference (SPID) over the 48-hour period (SPID48), a measure derived from the score on the Numeric Pain Rating Scale (range, 0 to 10; higher scores indicate greater pain) at 19 time points after the first dose of VX-548 or placebo. The main analysis compared each dose of VX-548 with placebo. RESULTS: A total of 303 participants were enrolled in the abdominoplasty trial and 274 in the bunionectomy trial. The least-squares mean difference between the high-dose VX-548 and placebo groups in the time-weighted SPID48 was 37.8 (95% confidence interval [CI], 9.2 to 66.4) after abdominoplasty and 36.8 (95% CI, 4.6 to 69.0) after bunionectomy. In both trials, participants who received lower doses of VX-548 had results similar to those with placebo. Headache and constipation were common adverse events with VX-548. CONCLUSIONS: As compared with placebo, VX-548 at the highest dose, but not at lower doses, reduced acute pain over a period of 48 hours after abdominoplasty or bunionectomy. VX-548 was associated with adverse events that were mild to moderate in severity. (Funded by Vertex Pharmaceuticals; VX21-548-101 and VX21-548-102 ClinicalTrials.gov numbers, NCT04977336 and NCT05034952.).
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Acetaminofen , Dor Aguda , Humanos , Acetaminofen/uso terapêutico , Hidrocodona/efeitos adversos , Dor Aguda/tratamento farmacológico , Analgésicos Opioides/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Analgésicos/uso terapêutico , Método Duplo-CegoRESUMO
OBJECTIVE: The language used to describe people with substance use disorder impacts stigma and influences clinical decision making. This study evaluates the presence of stigmatizing language (SL) in clinical notes and detects patient- and provider-level differences. METHODS: All free-text notes generated in a large health system for patients with substance-related diagnoses between December 2020 and November 2021 were included. A natural language processing algorithm using the National Institute on Drug Abuse's "Words Matter" list was developed to identify use of SL in context. RESULTS: There were 546,309 notes for 30,391 patients, of which 100,792 (18.4%) contained SL. A total of 18,727 patients (61.6%) had at least one note with SL. The most common SLs used were "abuse" and "substance abuse." Nurses were least likely to use SL (4.1%) while physician assistants were most likely (46.9%). Male patients were more likely than female patients to have SL in their notes (adjusted odds ratio [aOR], 1.17; 95% confidence internal [CI], 1.11-1.23), younger patients aged 18 to 24 were less likely to have SL than patients 45 to 54 years (aOR, 0.55; 95% CI, 0.50-0.61), Asian patients were less likely to have SL than White patients (aOR, 0.45; 95% CI, 0.36-0.56), and Hispanic patients were less likely to have SL than non-Hispanic patients (aOR, 0.88; 95% CI, 0.80-0.98). CONCLUSIONS: The majority of patients with substance-related diagnoses had at least one note containing SL. There were also several patient characteristic disparities associated with patients having SL in their notes. The work suggests that more clinician interventions about use of SL are needed.
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Idioma , Transtornos Relacionados ao Uso de Substâncias , Humanos , Masculino , Feminino , Incidência , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Disparidades em Assistência à SaúdeRESUMO
INTRODUCTION: As telehealth models for treatment of opioid use disorder (OUD) are expanding, the field does not know the reliability of urine drug screening (UDS) in this setting. The objective of this study is to determine the rate of falsification of UDS testing among patients with OUD in active treatment with buprenorphine via a telehealth provider. METHODS: This is a prospective cohort study of 899 randomly selected eligible patients, of which 392 participated in the final cohort that the study team used for analysis. The study mailed patients a UDS cup and asked them to return the sample by mail. After the UDS sample was received, a buccal swab was mailed, and the study asked patients to schedule a virtual meeting in which consent was sought and an observed buccal swab was obtained. We evaluated urine for evidence of falsification, and used buccal swabs to genetically match individuals to urine samples. RESULTS: After exclusion criteria, 395 (52.3 %) of 755 patients who received a UDS kit returned it for analysis prior to knowledge of the study. Of that, 392 samples had sufficient quantity for testing. We determined 383 (97.7 %) to be human urine containing buprenorphine without indication of exogenous buprenorphine addition and with evidence of compliance. A total of 374 patients received a buccal swab kit and 139 (37.2 %) attended the consent/observed buccal swab session. One hundred and thirty-two patients consented and completed the swab under video observation, and 120 successfully sent the swab back to the external laboratory. Of the 120 buccal swabs received, 109 (90.8 %) were a genetic match, 10 (8.3 %) were indeterminate, and 1 (0.8 %) was a genetic mismatch. CONCLUSIONS: This study of patients treated by a telehealth OUD provider demonstrated a low rate of urine test falsification.