Racial, Ethnic, and Sex Differences in Methadone-Involved Overdose Deaths Before and After the US Federal Policy Change Expanding Take-home Methadone Doses.

Importance: In March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) permitted states to relax restrictions on take-home methadone doses for treatment-adherent patients to minimize COVID-19 exposures. Objective: To assess whether the methadone take-home policy change was associated with drug overdose deaths among different racial, ethnic, and sex groups. Design, Setting, and Participants: Interrupted time series analysis from January 1, 2018, to June 30, 2022. Data analysis was conducted from February 18, 2023, to February 28, 2023. In this population-based cohort study of drug overdose mortality including 14 529 methadone-involved deaths, monthly counts of methadone-involved drug overdose deaths were obtained for 6 demographic groups: Hispanic men and women, non-Hispanic Black men and women, and non-Hispanic White men and women. Exposure: On March 16, 2020, in response to the first wave of the COVID-19 pandemic, SAMHSA issued an exemption to the states that permitted up to 28 days of take-home methadone for stable patients and 14 days for less stable patients. Main Outcome Measures: Monthly methadone-involved overdose deaths. Results: From January 1, 2018, to June 30, 2022 (54 months), there were 14 529 methadone-involved deaths in the United States; 14 112 (97.1%) occurred in the study's 6 demographic groups (Black men, 1234; Black women, 754; Hispanic men, 1061; Hispanic women, 520; White men, 5991; and White women, 4552). Among Black men, there was a decrease in monthly methadone deaths associated with the March 2020 policy change (change of slope from the preintervention period, -0.55 [95% CI, -0.95 to -0.15]). Hispanic men also experienced a decrease in monthly methadone deaths associated with the policy change (-0.42 [95% CI, -0.68 to -0.17]). Among Black women, Hispanic women, White men, and White women, the policy change was not associated with a change in monthly methadone deaths (Black women, -0.27 [95% CI, -1.13 to 0.59]; Hispanic women, 0.29 [95% CI, -0.46 to 1.04]; White men, -0.08 [95% CI, -1.05 to 0.88]; and White women, -0.43 [95% CI, -1.26 to 0.40]). Conclusions and Relevance: In this interrupted time series study of monthly methadone-involved overdose deaths, the take-home policy may have helped reduce deaths for Black and Hispanic men but had no association with deaths of Black or Hispanic women or White men or women.

Deimplementation in the provision of opioid agonist treatment to achieve equity of care for people engaged in treatment: a qualitative study.

BACKGROUND: Deimplementation, the removal or reduction of potentially hazardous approaches to care, is key to progressing social equity in health. While the benefits of opioid agonist treatment (OAT) are well-evidenced, wide variability in the provision of treatment attenuates positive outcomes. During the COVID-19 pandemic, OAT services deimplemented aspects of provision which had long been central to treatment in Australia; supervised dosing, urine drug screening, and frequent in-person attendance for review. This analysis explored how providers considered social inequity in health of patients in the deimplementation of restrictive OAT provision during the COVID-19 pandemic. METHODS: Between August and December 2020, semi-structured interviews were conducted with 29 OAT providers in Australia. Codes relating to the social determinants of client retention in OAT were clustered according to how providers considered deimplementation in relation to social inequities. Normalisation Process Theory was then used to analyse the clusters in relation to how providers understood their work during the COVID-19 pandemic as responding to systemic issues that condition OAT access. RESULTS: We explored four overarching themes based on constructs from Normalisation Process Theory: adaptive execution, cognitive participation, normative restructuring, and sustainment. Accounts of adaptive execution demonstrated tensions between providers' conceptions of equity and patient autonomy. Cognitive participation and normative restructuring were integral to the workability of rapid and drastic changes within the OAT services. Key transformative actors included communities of practice and "thought leaders" who had long supported deimplementation for more humane care. At this early stage of the pandemic, providers had already begun to consider how this period could inform sustainment of deimplementation. When considering a future, post-pandemic period, several providers expressed discomfort at operating with "evidence-enough" and called for narrowly defined types of data on adverse events (e.g. overdose) and expert consensus on takeaway doses. CONCLUSIONS: The possibilities for achieving social equity in health are limited by the divergent treatment goals of providers and people receiving OAT. Sustained and equitable deimplementation of obtrusive aspects of OAT provision require co-created treatment goals, patient-centred monitoring and evaluation, and access to a supportive community of practice for providers.

Clinics Optimizing MEthadone Take-homes for opioid use disorder (COMET): Protocol for a stepped-wedge randomized trial to facilitate clinic level changes.

INTRODUCTION: Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data. METHODS AND ANALYSIS: We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis. DISCUSSION: This multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level.

Trends in Methadone Dispensing for Opioid Use Disorder After Medicare Payment Policy Changes.

Importance: A significant proportion of Medicare beneficiaries have a diagnosed opioid use disorder (OUD). Methadone and buprenorphine are both effective medications for the treatment of OUD (MOUDs); however, Medicare did not cover methadone until 2020. Objective: To examine trends in methadone and buprenorphine dispensing among Medicare Advantage (MA) enrollees after 2 policy changes in 2020 related to methadone access. Design, Setting, and Participants: This cross-sectional analysis of temporal trends in methadone and buprenorphine treatment dispensing assessed MA beneficiary claims from January 1, 2019, through March 31, 2022, captured by Optum's Clinformatics Data Mart. Of 9 870 791 MA enrollees included in the database, 39 252 had at least 1 claim for methadone, buprenorphine, or both during the study period. All available MA enrollees were included. Subanalyses by age and dual eligibility for Medicare and Medicaid status were conducted. Exposures: Study exposures were (1) the Centers for Medicare & Medicaid Services (CMS) Medicare bundled payment reimbursement policy for OUD treatment and (2) the Substance Abuse and Mental Health Administration and CMS Medicare policies designed to facilitate access to treatment for OUD, specifically during the COVID-19 pandemic. Main Outcomes and Measures: Study outcomes were trends in methadone and buprenorphine dispensing by beneficiary characteristics. National methadone and buprenorphine dispensing rates were calculated as claims-based dispensing rates per 1000 MA enrollees. Results: Among the 39 252 MA enrollees with at least 1 MOUD dispensing claim (mean age, 58.6 [95% CI, 58.57-58.62] years; 45.9% female), 195 196 methadone claims and 540 564 buprenorphine pharmacy claims were identified, for a total of 735 760 dispensing claims. The methadone dispensing rate for MA enrollees was 0 in 2019 because the policy did not allow any payment until 2020. Claims rates per 1000 MA enrollees were low initially, increasing from 0.98 in the first quarter of 2020 to 4.71 in the first quarter of 2022. Increases were primarily associated with dually eligible beneficiaries and beneficiaries younger than 65 years. National buprenorphine dispensing rates were 4.64 per 1000 enrollees in quarter 1 of 2019, increasing to 7.45 per 1000 enrollees in quarter 1 of 2022. Conclusions and Relevance: This cross-sectional study found that methadone dispensing increased among Medicare beneficiaries after the policy changes. Rates of buprenorphine dispensing did not provide evidence that beneficiaries substituted buprenorphine for methadone. The 2 new CMS policies represent an important first step in increasing access to MOUD treatment for Medicare beneficiaries.

Synthesising evidence of the effects of COVID-19 regulatory changes on methadone treatment for opioid use disorder: implications for policy.

As the USA faces a worsening overdose crisis, improving access to evidence-based treatment for opioid use disorder (OUD) remains a policy priority. Federal regulatory changes in response to the COVID-19 pandemic substantially expanded flexibilities on take-home doses for methadone treatment for OUD. These changes have fuelled questions about the effect of new regulations on OUD outcomes and the potential effect on health of permanently integrating these flexibilities into treatment policy going forward. To aide US policy makers as they consider implementing permanent methadone regulatory changes, we conducted a review synthesising peer-reviewed research on the effect of the flexibilities of methadone take-home policies introduced during COVID-19 on methadone programme operations, OUD patient and provider experiences, and patient health outcomes. We interpret the findings in the context of the federal rule-making process and discuss avenues by which these findings can be incorporated and implemented into US policies on substance use treatment going forward.

SARS-CoV-2 antibody prevalence, correlates, and access to harm reduction services among people who inject drugs living with and without HIV and their partners in Kenya.

BACKGROUND: In sub-Saharan Africa many people who inject drugs (PWID) are living with undiagnosed or untreated HIV and experience high levels of poverty and conditions that can contribute to worse outcomes from SARS-CoV-2 infection. Identifying the burden of SARS-CoV-2 infection in marginalized populations like PWID may contribute to controlling the pandemic. METHODS: This is a nested cross-sectional study within an ongoing cohort study that recruits PWID living with HIV and their injecting and/or sexual partners at needle and syringe program sites and methadone clinics in Kenya. Blood samples were collected from consenting participants at enrollment to determine SARS-CoV-2 antibodies using a Platellia BioRad SARS-CoV-2 total antibody enzyme-linked immunosorbent assay. Baseline data were collected on HIV status, antiretroviral therapy and methadone adherence. We used logistic regression to identify factors associated with antibody positivity and descriptive statistics to report SARS-CoV-2 antibody prevalence. RESULTS: One thousand participants were enrolled between April and July 2021, of whom 323 (32.3%) were women and 677 (67.7%) were men. Median age of participants was 36 years (interquartile range: 30, 42). SARS-CoV-2 antibody positivity was found in 309 (30.9%) participants. Disruption in obtaining methadone service was reported by 106 (24.3%) of the participants. Men were significantly less likely than women to have SARS-CoV-2 antibodies (adjusted odds ratio [aOR] = 0.68, 95% confidence interval [CI] 0.51, 0.95; p < 0.01) Participants who reported a sexual or injecting partner diagnosed with SARS-CoV-2 were twofold more likely to have SARS-CoV-2 antibodies detected (aOR = 2.21, 95% CI 1.06, 4.58; p < 0.032). Living with HIV was not associated with presence of SARS-CoV-2 antibodies. CONCLUSION: The seroprevalence of SARS-CoV-2 of 30.9% in this cohort suggests high transmission rates within this population. SARS-CoV-2 seroprevalence was similar for people living with and without HIV. A large portion of this population was noted to have had disruption in access to harm reduction services.

"Sign Me Up": a qualitative study of video observed therapy (VOT) for patients receiving expedited methadone take-homes during the COVID-19 pandemic.

BACKGROUND: Federal and state regulations require frequent direct observation of methadone ingestion at an Opioid Treatment Program (OTP)-a requirement that creates barriers to patient access. Video observed therapy (VOT) may help to address public health and safety concerns of providing take-home medications while simultaneously reducing barriers to treatment access and long-term retention. Evaluating user experiences with VOT is important for understanding the acceptability of this strategy. METHODS: We conducted a qualitative evaluation of a clinical pilot program of VOT via smartphone that was rapidly implemented between April and August 2020 during the COVID-19 pandemic within three opioid treatment programs. In the program, selected patients submitted video recordings of themselves ingesting methadone take-home doses, which were asynchronously reviewed by their counselor. We recruited participating patients and counselors for semi-structured, individual interviews to explore their VOT experiences after program completion. Interviews were audio recorded and transcribed. Transcripts were analyzed using thematic analysis to identify key factors influencing acceptability and the effect of VOT on the treatment experience. RESULTS: We interviewed 12 of the 60 patients who participated in the clinical pilot and 3 of the 5 counselors. Overall, patients were enthusiastic about VOT, noting multiple benefits over traditional treatment experiences, including avoiding frequent travel to the clinic. Some noted how this allowed them to better meet recovery goals by avoiding a potentially triggering environment. Most appreciated having increased time to devote to other life priorities, including maintaining consistent employment. Participants described how VOT increased their autonomy, allowed them to keep treatment private, and normalized treatment to align with other medications that do not require in-person dosing. Participants did not describe major usability issues or privacy concerns with submitting videos. Some participants reported feeling disconnected from counselors while others felt more connected. Counselors felt some discomfort in their new role confirming medication ingestion but saw VOT as a useful tool for select patients. CONCLUSIONS: VOT may be an acceptable tool to achieve equipoise between lowering barriers to treatment with methadone and protecting the health and safety of patients and their communities.

Long-term wastewater-based surveillance and impacts of the COVID-19 pandemic on drug use trends in a U.S. Northeast rural town.

Herein we discuss the findings of a two-year wastewater-based drug use surveillance from September 2018 to August 2020 and present objective evidence on the impacts of the COVID-19 pandemic on drug use in a rural community. 24-h composite wastewater samples were collected twice each month from a university town in Northeastern United States and were analyzed for ten priority opioids and stimulants: morphine, codeine, hydrocodone, methadone, fentanyl cocaine, methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine (MDMA), and 3,4-methylenedioxy-N-ethylamphetamine (MDEA). All target drugs were detected at 100 % frequency in wastewater samples. On a mass basis, the average estimated per capita drug consumption were highest for cocaine, morphine, and amphetamine, and lowest for MDMA, MDEA, and hydrocodone. Furthermore, the estimated per capita consumption of fentanyl was higher than previous reports from rural and university settings in the U.S. Generally, drug consumption was higher during the spring semesters, with year-on-year semester increases also noted over the 2-y study period. Except for methadone and cocaine, the estimated average per capita consumption of drugs increased over the pandemic period, with the highest increase noted for MDMA (286 % increase compared to baseline, p = 0.016). Estimated average consumption of methadone and cocaine decreased slightly by 6 % and 7 %, respectively. These results demonstrate the utility and strength of wastewater-based approaches in capturing long-term and evolving trends in drug use within communities. Our study findings reflect the regionwide problem with opioid-related overdoses and increasing stimulant prescription rates. Our findings also provide objective data and insights for health policymakers on the effects of the pandemic period on community drug use in a rural U.S. town.

Patient experiences of methadone treatment changes during the first wave of COVID-19: a national community-driven survey.

BACKGROUND: During COVID-19, the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed Methadone Maintenance Treatment (MMT) programs to relax in-person MMT requirements to reduce COVID-19 exposure. This study examines patient-reported changes to in-person methadone clinic attendance requirements during COVID-19. METHODS: From June 7, 2020, to July 15, 2020, a convenience sample of methadone patients (N = 392) were recruited in collaboration with National Survivors Union (NSU) in 43 states and Washington D.C. through social media (Facebook, Reddit, Twitter, and Web site pop-ups). The community-driven research (CDR) online survey collected information on how patient take-home methadone dosing and in-person drug testing, counseling, and clinic visit frequency changed prior to COVID-19 (before March 2020) to during COVID-19 (June and July 2020). RESULTS: During the study time period, the percentage of respondents receiving at least 14 days of take-home doses increased from 22 to 53%, while the percentage receiving one or no take-home doses decreased from 22.4% before COVID-19 to 10.2% during COVID-19. In-person counseling attendance decreased from 82.9% to 19.4%. While only 3.3% of respondents accessed counseling through telehealth before COVID-19, this percentage increased to 61.7% during COVID-19. Many respondents (41.3%) reported visiting their clinics in person once a week or more during COVID-19. CONCLUSIONS: During the first wave of COVID-19, methadone patients report decreased in-person clinic attendance and increased take-home doses and use of telehealth for counseling services. However, respondents reported considerable variations, and many were still required to make frequent in-person clinic visits, which put patients at risk of COVID-19 exposure. Relaxations of MMT in-person requirements during COVID-19 should be consistently implemented and made permanent, and patient experiences of these changes should be explored further.

Do the lockdown-imposed changes in a wastewater treatment plant catchment's socio-demographics impact longitudinal temporal trends in psychoactive pharmaceutical use?

Wastewater-based epidemiology (WBE) includes the analysis of human metabolic biomarkers of xenobiotics in influent wastewater. WBE complements existing drug utilization approaches and provides objective, spatio-temporal information on the consumption of pharmaceuticals in the general population. This approach was applied to 24-h composite influent wastewater samples from Leuven, Belgium. Daily samples were analysed from September 2019 to December 2019 (n = 76), and on three days of the week (Monday, Wednesday, Saturday) from January 2020 to April 2022 (n = 367). Sample analysis consisted of 96-well solid-phase extraction and liquid chromatography coupled to tandem mass spectrometry. Measured concentrations of 21 biomarkers for antidepressant and opioid use were converted to population-normalized mass loads (PNML) by considering the flow rate and catchment population. To capture population movements, mobile phone data was used. Amitriptyline, hydroxy-bupropion, norcitalopram, citalopram, normirtazapine, trazodone, O-desmethylvenlafaxine, codeine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), methadone, morphine, O-desmethyltramadol, and tramadol were included in the temporal assessment since concentrations were above the lower limit of quantification. The PNML of most biomarkers increased (with 3-119 %) throughout the sampling period. The population disruption during the COVID-19 pandemic led to a major change in the socio-demographics of the catchment area, resulting in temporal differences in the PNML of the different biomarkers. As such, higher PNML were observed during the different lockdown phases, which were characterized by the outflow of university students and a decreasing commuting in and out the catchment area. The effects of the fluctuating socio-demographics of the catchment population were further evidenced by the different week-weekend pattern of PNMLs over the course of the sampling campaign. Mean parent/metabolite ratios (i.e., citalopram/norcitalopram, tramadol/O-desmethyltramadol, venlafaxine/O-desmethylvenlafaxine, and methadone/EDDP) remained relatively stable throughout the entire sampling campaign (RSD% below 25 % for all ratios, except for methadone/EDDP) and therefore were not affected by this population change.

Patients' perceptions of self-administered dosing to opioid agonist treatment and other changes during the COVID-19 pandemic: a qualitative study.

OBJECTIVES: During the COVID-19 pandemic, addiction treatment services received official guidance asking them to limit face-to-face contact with patients and to prescribe opioid agonist treatment (OAT) medication flexibly. With the aim for most patients to receive take-home supplies for self-administration rather than attendance for observed daily dosing. DESIGN: This was a theory-driven, clinically applied qualitative study, with data for thematic analysis collected by semi-structured, audio-recorded, telephone interviews. PARTICIPANTS: Twenty-seven adults (aged ≥18 years) enrolled in sublingual (tablet) buprenorphine and oral (liquid) methadone OAT. SETTING: Community addictions centre in the London Borough of Lambeth operated by South London and Maudsley NHS Trust. RESULTS: Three major themes were identified: (1) dissatisfaction and perceived stigma with OAT medication dispensing arrangements before the pandemic; (2) positive adaptations in response to COVID-19 by services; (3) participants recommended that, according to preference and evidence of adherence, OAT should be personalised to offer increasing medication supplies for self-administration from as early as 7 days after commencement of maintenance prescribing. CONCLUSIONS: In an applied qualitative study of patients enrolled in OAT during the COVID-19 pandemic, participants endorsed their opportunity to take medication themselves at home and with virtual addiction support. Most patients described a preference for self-administration with increased dispensing supplies, from as early as 7 days into maintenance treatment, if they could demonstrate adherence to their prescription.

Incremental expenditures attributable to daily dispensation and witnessed ingestion for opioid agonist treatment in British Columbia: 2014-20.

BACKGROUND AND AIM: While daily witnessed opioid agonist treatment (OAT) ingestion is common in British Columbia (BC), Canada, and elsewhere, sparse evidence supports this resource-intensive practice. Many settings across North America relaxed restrictions for take-home dosing during the COVID-19 pandemic and have reported consistent or improved patient outcomes. This study measured excess expenditures attributed to daily witnessed pharmacy dispensing compared with weekly or biweekly dispensation schedules. DESIGN, SETTING AND PARTICIPANTS: This study was a population-level retrospective analysis. We included all methadone, buprenorphine/naloxone and slow-release oral morphine dispensations in BC from 1 January 2014 to 30 December 2020. A total of 24 357 107 OAT dispensations among 51 195 unique individuals with 122 793 person-years of follow-up were included during the study period. MEASUREMENTS: Total expenditures for each person-week of OAT with an estimated expenditure under two scenarios are as follows: (1) a weekly dispensation scenario and (2) a biweekly dispensation scenario. FINDINGS: We estimated excess expenditures attributable to current dispensing practices of between $38 million (2014) and $47.4 million (2018) compared with a hypothetical weekly dispensing schedule, and $43.9 million (2014) to $54.9 million (2018) compared with biweekly dispensing. The majority of these expenditures (58-64%) were attributed to pharmacy dispensing fees ($23 million in 2014 to $30 million in 2018 compared with weekly dispensing; $26.6 million in 2014 to $34.7 million in 2018 compared with biweekly dispensing). CONCLUSION: Daily witnessed opioid agonist treatment ingestion results in more than $30 million in excess expenditures annually in the province of British Columbia, Canada compared with the costs of weekly or biweekly dispensation schedules.

Availability of timely methadone treatment in the United States and Canada during COVID-19: A census tract-level analysis.

OBJECTIVES: We sought to compare timely access to methadone treatment in the United States (US) and Canada during the COVID-19 pandemic. METHODS: We conducted a cross-sectional study of census tracts and aggregated dissemination areas (used for rural Canada) within 14 US and 3 Canadian jurisdictions in 2020. We excluded census tracts or areas with a population density of less than one person per square km. Data from a 2020 audit of timely medication access was used to determine clinics accepting new patients within 48 h. Unadjusted and adjusted linear regressions were performed to examine the relationship between area population density and sociodemographic covariates and three outcome variables: 1) driving distance to the nearest methadone clinic accepting new patients, 2) driving distance to the nearest methadone clinic accepting new patients for medication initiation within 48 h, and 3) the difference in the driving distance between the first and second outcome. RESULTS: We included 17,611 census tracts and areas with a population density greater than one person per square kilometer. After adjusting for area covariates, US jurisdictions were a median of 11.6 miles (p value <0.001) further from a methadone clinic accepting new patients and 25.1 miles (p value <0.001) further from a clinic accepting new patients within 48 h than Canadian jurisdictions. CONCLUSIONS: These results suggest that the more flexible Canadian regulatory approach to methadone treatment is associated with a greater availability of timely methadone treatment and reduced urban-rural disparity in availability, compared to the US.

Examination of methadone involved overdoses during the COVID-19 pandemic.

BACKGROUND: The US opioid overdose epidemic continues to escalate. The restrictions on methadone availability including take-home dosing were loosened during the COVID-19 pandemic although there have been concerns about the high street value of diverted methadone. This report examined how fatal overdoses involving methadone have changed over the past two-decades including during the pandemic. METHODS: The CDC's Wide-ranging Online Data for Epidemiologic Research (WONDER) was used to find the unintentional methadone related overdose death rate from 1999 to 2020. Unintentional methadone deaths were defined using the ICD X40-44 codes with only data for methadone (T40.3). Data from the DEA's Automation of Reports and Consolidated Orders System (ARCOS) on methadone overall use, opioid treatment programs use, and pain management use was gathered for all states for 2020 and corrected for population. RESULTS: There have been dynamic changes over the past two-decades in methadone overdoses. Overdoses increased from 1999 (0.9/million) to 2007 (15.9) and declined until 2019 (6.5). Overdoses in 2020 (9.6) were 48.1% higher than in 2019 (t(50) = 3.05, p < .005). The state level correlations between overall methadone use (r(49) = +0.75, p < .001), and opioid treatment program use (r(49) = +0.77, p < .001) with overdoses were positive, strong, and statistically significant. However, methadone use for pain treatment was not associated with methadone overdoses (r(49) = -0.08). CONCLUSIONS: Overdoses involving methadone significantly increased by 48.1% in 2020 relative to 2019. Policy changes that were implemented following the COVID-19 pandemic involving methadone take-homes may warrant further study before they are made permanent.

Patient experiences of COVID-19-induced changes to methadone treatment in a large community-based opioid treatment program in Baltimore.

INTRODUCTION: Following the March 2020 federal declaration of a COVID-19 public health emergency, in line with recommendations for social distancing and decreased congregation, federal agencies issued sweeping regulation changes to facilitate access to medications for opioid use disorder (MOUD) treatment. These changes allowed patients new to treatment to receive multiple days of take-home medications (THM) and to use remote technology for treatment encounters-allowances that previously had been reserved exclusively for "stable" patients who met minimum adherence and time-in-treatment criteria. The impact of these changes on low-income, minoritized patients (frequently the largest recipients of opioid treatment program [OTP]-based addiction care), however, is not well characterized. We aimed to explore the experiences of patients who were enrolled in treatment prior to COVID-19 OTP regulation changes, with the goal of understanding patients' perceptions of the impact of these changes on treatment. METHODS: This study included semistructured, qualitative interviews with 28 patients. We used a purposeful sampling method to recruit individuals who were active in treatment just before COVID-19-related policy changes went into effect, and who were still in treatment several months later. To ensure a diverse array of perspectives, we interviewed individuals who either had or had not experienced challenges with methadone medication adherence from 3/24/21 to 6/8/21, approximately 12-15 months following the onset of COVID-19. Interviews were transcribed and coded using thematic analysis. RESULTS: Participants were majority male (57 %), Black/African American (57 %), with a mean age of 50.1 (SD = 9.3). Fifty percent received THM prior to COVID-19, which increased to 93 % during the pandemic. COVID-19 program changes had mixed effects on treatment and recovery experiences. Themes identified convenience, safety, and employment as reasons for preferring THM. Challenges included difficulty with managing/storing medications, experiencing isolation, and concern about relapse. Furthermore, some participants reported that telebehavioral health encounters felt less personal. CONCLUSIONS: Policymakers should consider patients' perspectives to foster a more patient-centered approach to methadone dosing that is safe, flexible, and accommodating to a diverse array of patients' needs. Additionally, technical support should be provided to OTPs to ensure interpersonal connections are maintained in the patient-provider relationship beyond the pandemic.

Inability to contact opioid agonist therapy prescribers during the COVID-19 pandemic in a Canadian setting: a cross-sectional analysis among people on opioid agonist therapy.

BACKGROUND: The COVID-19 pandemic and consequent public health response may have undermined key responses to the protracted drug poisoning crisis, including reduced access to opioid agonist therapy (OAT) among people with opioid use disorder. Our study objectives were to estimate the prevalence of and identify factors associated with inability to contact OAT prescribers when in need among people on OAT in a Canadian setting during the dual public health crises. METHODS: Survey data were collected from three prospective cohort studies of community-recruited people who use drugs between July and November 2020, in Vancouver, Canada. A multivariable logistic regression analysis was used to identify potential factors associated with inability to contact OAT prescribers among patients who accessed OAT in the past 6 months. RESULTS: Among 448 respondents who reported accessing OAT in the past 6 months, including 231 (54.9%) men, 85 (19.0%) reported having been unable to contact OAT prescribers when needed, whereas 268 (59.8%) reported being able to talk to their prescriber when needed, and 95 (21.2%) reported that they did not want to talk to their medication prescriber in the previous 6 months. Among those who reported inability to contact prescribers, 45 (53.6%) reported that their overall ability to contact prescribers decreased since the start of the pandemic. In multivariable analyses, factors independently associated with inability to talk to OAT prescribers included: chronic pain (Adjusted Odds Ratio [AOR] = 1.82; 95% Confidence Interval [CI] 1.02, 3.27), moderate to severe symptoms of depression or anxiety (AOR = 4.74; 95% CI 2.30, 9.76), inability to access health/social services (AOR = 2.66; 95% CI 1.41, 5.02), and inability to self-isolate or socially distance most or all of the time (AOR = 2.13; 95% CI 1.10, 4.14). CONCLUSIONS: Overall, approximately one fifth of the sample reported inability to contact their OAT prescribers when needed, and those people were more likely to have co-occurring vulnerabilities (i.e., co-morbidities, inability to access health/social services) and higher vulnerability to COVID-19. Interventions are needed to ensure optimal access to OAT and mitigate the deepening health inequities resulting from the COVID-19 pandemic and the escalating drug poisoning crisis.

Shifting Medication Treatment Practices in the COVID-19 Pandemic: A Statewide Survey of Pennsylvania Opioid Treatment Programs.

OBJECTIVES: We sought to understand how opioid treatment programs (OTPs) adapted OTP operations to the COVID-19 pandemic and new federal regulations around methadone and buprenorphine. METHODS: In fall 2020, we conducted an online survey of all 103 OTPs licensed by the Pennsylvania Department of Drug and Alcohol Programs, including clinical directors. Survey domains included changes to methadone take-home and telehealth practices; overdose and diversion prevention tactics; perceptions regarding how such changes influence patient well-being; and financial/operational concerns related to the new policies and practices. We calculated descriptive statistics and conducted Chi-square test to test for differences between not-for-profit versus for-profit and large versus small OTPs. RESULTS: Forty-seven percent (46%) OTPs responded to the survey. 10% and 25%, respectively, endorsed offering telephone and video-based telemedicine buprenorphine induction. Sixty-six percent endorsed extending take-home supplies of methadone, but most indicated that these extensions applied to a minority of their patients. Most respondents agreed that provision of buprenorphine via telehealth and extended take-home methadone reduced patient burden in accessing medications and prevented exposure to COVID-19, while not significantly increasing risk of overdose. We did not find major differences in COVID-19 practice modifications by nonprofit status or size of OTP. CONCLUSIONS: In Pennsylvania, the COVID-19 pandemic led to rapid changes in provision of opioid treatment services. Findings on relatively low uptake of longer methadone take-home regimens and virtual buprenorphine initiation despite general support for these practices imply a need to further develop guidelines for best clinical practices and understand/address barriers to their implementation.

Methadone-involved overdose deaths in the United States before and during the COVID-19 pandemic.

BACKGROUND: Few studies have characterized methadone-involved overdose deaths in the US since 2014 despite changing patterns of opioid use, the onset of the COVID-19 pandemic, and changes to take-home dose guidance in opioid treatment programs (OTPs) in March 2020. METHODS: Data on monthly overdose deaths in the US from January 1, 2007 to March 31, 2021 were obtained through CDC WONDER. Interrupted time series models were used to assess for changes in series levels starting in April 2020. Analyses were stratified by involvement of synthetic opioids in overdose deaths. RESULTS: An increase in methadone-involved overdoses of 105.4 deaths per month (95 % CI: 73.8-137.0) occurred starting in April 2020 compared with prior trends (p < 0.001). Trends in methadone-involved overdose deaths showed a step increase starting in April 2020 both with (54.2 deaths per month; 95 % CI: 39.4-68.9) and without (51.7 deaths per month; 95 % CI: 23.4-78.0) synthetic opioid involvement (p < 0.001 for both). Among overdose deaths without synthetic opioids, the increase in methadone-involved overdose deaths accounted for 26.5 % of the increase between the 12-month periods before and after March 2020. The relative percentage increase in methadone-involved overdose deaths, both with and without synthetic opioid co-involvement, was highest among Hispanic and non-Hispanic Black individuals. CONCLUSIONS: Methadone-involved overdose deaths, both with and without other synthetic opioid co-involvement, increased during the 12-month period after March 2020, compared with prior trends. These results provide a cautionary addition to previous findings of no or limited methadone-related harms after the US regulatory changes during the COVID-19 pandemic.

Acceptability, feasibility, and outcomes of a clinical pilot program for video observation of methadone take-home dosing during the COVID-19 pandemic.

BACKGROUND: Methadone is one of the most utilized treatments for opioid use disorder. However, requirements for observing methadone dosing can impose barriers to patients and increase risk for respiratory illness transmission (e.g., COVID-19). Video observation of methadone dosing at home could allow opioid treatment programs (OTPs) to offer more take-home doses while ensuring patient safety through remote observation of ingestion. METHODS: Between April and August 2020, a clinical pilot program of video observation of methadone take-home dosing via smartphone was conducted within a multisite OTP agency. Participating patients completed a COVID-19 symptom screener and submitted video recordings of themselves ingesting all methadone take-home doses. Patients who followed these procedures for a two-week trial period could continue participating in the full pilot program and potentially receive more take-home doses. This retrospective observational study characterizes patient engagement and compares clinical outcomes with matched controls. RESULTS: Of 44 patients who initiated the two-week trial, 33 (75 %) were successful and continued participating in the full pilot program. Twenty full pilot participants (61 %) received increased take-home doses. Full pilot participants had more days with observed dosing over a 60-day period than matched controls (mean = 53.2 vs. 16.6 days, respectively). Clinical outcomes were similar between pilot participants and matched controls. CONCLUSIONS: Video observation of methadone take-home dosing implemented during the COVID-19 pandemic was feasible. This model has the potential to enhance safety by increasing rates of observed methadone dosing and reducing infection risks and barriers associated with relying solely on face-to-face observation of methadone dosing.