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The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already exist-like evidence-based medications-are not being deployed to maximum impact. To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.

Abstract Background Pharmacological options for refractory cancer pain are limited. This study aimed to investigate the efficacy and safety of the combined use of low-dose methadone and ongoing opioid treatment for uncontrolled cancer pain. Methods This was a prospective, open-label study. Participants were patients with uncontrolled cancer pain despite dose titration of opioids. Patients received low-dose methadone (starting dose of 5 or 10 mg/day) combined with another ongoing opioid therapy. The primary outcome was the proportion of responders (defined as ≥33% reduction in average pain intensity on the numerical rating scale [NRS]) on day 15. Pain intensity and adverse events according to the Patient-Reported Outcome Common Terminology Criteria for Adverse Events were evaluated at baseline, on days 8 and 15. Results Nineteen patients participated in this study, 11 (57.9%) of whom had neuropathic pain. The mean daily oral morphine equivalent dose before combination was 112.6 mg. The primary outcome occurred in 13 (68.4%) of patients (95% CI, 43.4 to 87.4). The mean average NRS was 5.9 at baseline, which decreased significantly to 4.2 and 3.3 on days 8 and 15 (P < .001), respectively. The worst pain intensity on NRS decreased significantly over time. Adverse effects, including nausea, vomiting, constipation, and somnolence, which were new or had worsened from baseline, were reported in 26.3%, 26.3%, 5.3%, and 26.3%, respectively. Delirium was observed in one patient. Conclusion Low-dose methadone with ongoing opioid treatment shows potential efficacy in the management of uncontrolled pain with acceptable adverse events. ClinicalTrials.gov identifier UMIN000038924

Abstract Aim The aim of this study was to assess the efficacy and adverse effects of methadone when used as first-line therapy in patients that are either receiving low doses of opioids or none. Methods Patients with advanced cancer were prospectively assessed. Opioid-naive patients (L-group) were started with methadone at 6 mg/day. Patients receiving weak or other opioids in doses of <60 mg/day of OME (H-group) were started with methadone at 9 mg/day. Methadone doses were changed according to the clinical needs to obtain the most favorable balance between analgesia and adverse effects. Edmonton Symptom Asssement Score (ESAS), Memorial Delirium Assessment Score (MDAS), doses of methadone, and the use of adjuvant drugs were recorded before starting the study treatment (T0), 1 week after (T7), 2 weeks after (T14), 1 month after (T30), and 2 months after (T60). Methadone escalation index percent (MEI%) and in mg (MEImg) were calculated at T30 and T60. Results Eighty-two patients were assessed. In both groups H and L, there were significant changes in pain and symptom intensity at the different times during the study. Adverse effects as causes of drop-out were minimal. Mean MEImg was 0.09 (SD 0.28) and 0.02 (SD 0.07) at T30 and T60, respectively. MEI% was 1.01 (SD 3.08) and 0.27 (SD 0.86) at T30 and T60, respectively. Conclusion Methadone used as a first-line opioid therapy provided good analgesia with limited adverse effects and a minimal opioid-induced tolerance. This article assesses the efficacy and adverse effects of methadone when used as first-line therapy in patients who are receiving either low doses of opioids or none.

The introduction of synthetic opiates and non-opiate sedatives into the illicit drug market has increased overdose risk for individuals who use opiates and other drugs. The ongoing risk of overdose for patients receiving methadone as a medication for opioid use disorder in the context of this more potent and less predictable drug supply is not well characterized. Additionally, little research has explored whether commonly available clinical data (including data available even in low resource settings) can predict near-term acute overdose in patients prescribed methadone for opioid use disorder. To determine whether the number of recent no-shows to scheduled clinic appointments in the past 30 days is associated with 30-day overdose risk among patients enrolled in one Opioid Treatment Program who are prescribed methadone for opioid use disorder. We analyzed clinical records from 1,049 patients in an opioid treatment program (May 2020-April 2024), and for each patient-day, counted the number of no-shows to scheduled clinic appointments (not methadone administrations) in the previous 30 days. Associations between the number of standardized no-shows in the past 30 days and overdose in the subsequent 30 days were analyzed with logistic regression via generalized linear model controlling for temporal and patient-specific variables. Goodness of fit was assessed with marginal R2 and a simulation-based approach designed for multilevel models. The sample included 56 overdoses with an average of 0.919 no-shows in the last 30 days (std. dev 1.37). The z-standardized number of no-shows to scheduled appointments in the past 30 days was both statistically and clinically significantly associated with risk of overdose in the next 30 days adjusting for study month and season (odds ratio 1.18 [95% CI 1.13-1.23] P < 0.001), as well as adjusting for demographics and overdoses during study period (odds ratio 1.28 [95% CI 1.22-1.34] P < 0.001), and a marginal R2 of 0.04. Model diagnostics revealed adequate fit using a generalized additive model, with results virtually unchanged from the generalized linear model. No-shows to scheduled clinic appointments in the past 30 days are significantly associated with overdose risk in the next 30 days with a linear relationship among patients receiving methadone in a single opioid treatment program. Population-specific acute risk prediction tools could help clinicians prioritize resources for timely intervention.

Postoperative pain is significant in cardiac surgical patients. Perioperative analgesia with intermittent administration of opioids can result in significant fluctuations in serum opioid concentrations. Methadone should provide a rapid onset and long-term pain relief upon a single intravenous dose at induction of anesthesia, and may reduce chronic postsurgical pain (CPSP) in cardiac surgical patients. The feasibility of using intravenous methadone in Chinese cardiac surgical patients, and its effect on acute and chronic pain management after cardiac surgery will be evaluated. A single-center, prospective, randomized-controlled pilot trial. Adult cardiac surgical patients will be randomized to receive 0.2 mg/kg methadone or morphine at induction of anesthesia. Patient-controlled analgesia morphine protocol, oral paracetamol and dihydrocodeine will be given for postoperative analgesia. Venous blood sampling for plasma methadone concentration will be obtained at regular intervals from study drug infusion to 96 hours after administration. The primary outcome will be a description of study feasibility, encompassing recruitment and retention, protocol adherence and stakeholder acceptability. Secondary outcomes include the time of ventilator weaning to spontaneous breathing, time of extubation, morphine requirements within 24 hours and 72 hours after surgery, time to first morphine rescue, postoperative pain scores, patient satisfaction, and length of stay in ICU and hospital. Opioid-related side effects including sedation, nausea and vomiting, and time to first bowel opening will be recorded. CPSP will be assessed with Neuropathic Pain Scale and Pain Catastrophizing Scale at 3 and 6 months after surgery. Randomized controlled trials on intravenous methadone in cardiac surgical patients are scarce, with none in Chinese populations. This study, supported by plasma methadone concentration analysis, will establish a basis for future large-scale research aimed at improving recovery through optimized pain management. ClinicalTrials.gov NCT05913284.

Purpose Refractory cancer-induced bone pain (CIBP) affects a patient’s functional capacity and quality of life, but there is limited evidence to guide opioid choice. We assessed the feasibility, tolerability and possible efficacy of methadone rotation (MR) compared to other opioid rotations (OOR) in this cohort. Methods Adults with CIBP and worst pain intensity ≥ 4/10 and/or opioid toxicity graded ≥ 2 on the Common Terminology Criteria for Adverse Events were randomised 1:1 to methadone or another opioid rotation. Standardised assessment tools were used at pre-defined study time points up to 14 days. Results Of 51 eligible participants, 38 (74.5%) consented, and 29 (76.3%, MR: 14, OOR: 15) completed the fourteen days follow-up post-opioid rotation. Both groups displayed significant reduction in average (MR: d  =  − 1.2, p  = 0.003, OOR: d  =  − 0.8, p  = 0.015) and worst pain (MR: d  =  − 0.9, p  = 0.042, OOR: d  =  − 0.6, p  = 0.048) and total pain interference score (MR: d  =  − 1.1, p  = 0.042, OOR: d  =  − 0.7, p  = 0.007). Oral morphine equivalent daily dose was reduced significantly in MR compared to the OOR group ( d  =  − 0.8, p  = 0.05). The incidence of opioid-related adverse events following MR was unchanged but lower in the OOR group ( d  = 0.9, 95% CI 0.1,1.7, p  = 0.022). There were no within-group or between-group differences in satisfaction with analgesia at the end of the study. Conclusion This pilot study demonstrated that MR and OOR in patients with refractory CIBP are feasible, safe and acceptable to patients. Appropriately powered multi-centre randomised controlled studies are needed to confirm the efficacy of MR and OOR in this cohort. Trial registration ACTRN12621000141842 registered 11 February 2021.

Methadone is an effective treatment for opioid use disorder; however, its provision in the US is limited to federally-regulated opioid treatment programs (OTP). Expansion of methadone treatment into non-OTP substance use disorder (SUD) treatment programs ('expanded methadone treatment access') is a promising intervention to increase access. We performed a cross-sectional geospatial analysis of public transit times to OTPs, expanded methadone treatment access, and other healthcare facilities as of March, 2024 in New York City (NYC). We estimated one-way public transit travel time and compared travel times using population weighted paired t-tests. For OTPs, 38.2% (95% CI: 38.0, 38.4) of the NYC population was within 15 minutes and 79.7% (95% CI: 79.5, 79.9) was within 30 minutes. For expanded methadone treatment access, 72.1% (95% CI: 71.9, 72.2) of the NYC population was within 15 minutes and 97.5% (95% CI: 97.5, 97.6) was within 30 minutes. The mean travel time was 20.4 minutes (SD: 10.9) for OTPs and 12.1 minutes (SD: 7.1) for expanded methadone treatment access (difference: -8.3 minutes [95% CI: -8.5, -8.1]; P < 0.001). The mean travel time for expanded methadone treatment access was slightly longer than the mean travel time for dialysis facilities (difference: 0.22 minutes [95% CI: 0.06, 0.39]; P = 0.009]), not significantly different than Federally Qualified Health Centers (difference: -0.06 minutes [95% CI: -0.22, 0.11]; P = 0.51), and significantly shorter than the mean travel time to ambulatory surgical centers (difference: -6.3 [95% CI: -6.5, -6.0]; P < 0.001) and hospitals (difference: -8.1 [95% CI: -8.3, -7.9]; P < 0.001). Efforts to increase access to methadone treatment in the US should promote expansion to additional non-OTP outpatient SUD treatment programs. Such integration is anticipated to increase spatial accessibility of methadone treatment substantially, greatly enhancing the potential for patient access.

To understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic. This community-based participatory and action research study involved one-hour, audio-recorded field interviews conducted with 131 people who used methadone and/or buprenorphine to address opioid use disorder at some point during COVID (January 1, 2020- March 31, 2021) in Arizona. Transcribed data were analyzed using a priori codes focused on federally recommended flexibilities governing MOUD access. Data were quantitated to investigate associations with COVID risk and services access. Telehealth was reported by 71.0% of participants, but the majority were required to come to the clinic to attend video appointments with an offsite provider. Risk for severe COVID outcomes was reported by 40.5% of the sample. Thirty-eight percent of the sample and 39.7% of methadone patients were required to be at the clinic daily to get medication and 47.6% were at high risk for COVID severe outcomes. About half (54.2%) of methadone patients indicated that some form of multi-day take home dosing was offered at their clinic, and 45.8% were offered an extra day or two of multi-day doses; but no participants received the federally allowed 14- or 28-day methadone take-home doses for unstable and stable patients respectively. All participants expressed that daily clinic visits interrupted their work and home lives and desired more take-home dosing and home delivery options. MOUD patients in Arizona were not offered many of the federally allowed flexibilities for access that were designed to reduce their need to be at the clinic. To understand the impact of these recommended treatment changes in Arizona, and other states where they were not well implemented, federal and state regulators must mandate these changes and support MOUD providers to implement them.

Cancer pain is the most common symptom of cancer. The implementation of the cancer pain guidelines depends on availability of and accessibility to guideline-recommended medications. The purpose of this research was to investigate the availability and accessibility of strong opioids in Eastern Europe and Balkans. The survey was conducted among 15 countries of the region with data collected for morphine, hydromorphone, oxycodone, methadone, transdermal fentanyl (fentanyl TD) and fentanyl for the breakthrough pain (fentanyl BTP). Methadone for substitution therapy was not included in this survey. Availability was evaluated by the formulary availability and marketing authorization. Accessibility was evaluated by the National Health Insurance Fund coverage as fully reimbursed, partially reimbursed or not accessible (out-of-pocket). Slovenia is the only country with all investigated strong opioids available and fully reimbursed (Table 1). Morphine is available and fully reimbursed in all countries. Fentanyl TD is available and fully reimbursed in 14/15 countries except in Albania in which it is out-of-pocket medication. Morphine in the only available and fully reimbursed strong opioid in Albania. Hydromorphone, oxycodone, methadone and fentanyl BTP are not available in 8/15, 4/15, 6/15 and 4/15 countries, respectively. All countries have at least one first-line strong opioid available and accessible with major differences among countries in the region.