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.

"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.

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.

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.

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.

An adaptive design to screen, treat, and retain people with opioid use disorders who use methamphetamine in methadone clinics (STAR-OM): study protocol of a clinical trial.

BACKGROUND: Methamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions, and their implementation barriers in Vietnam. METHOD: Design: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions. PARTICIPANTS: We will recruit 600 participants in 20 methadone clinics. ELIGIBILITY CRITERIA: (1) age 16+; (2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores ≥ 10 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone. OUTCOMES: Outcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (1) increase in HIV viral suppression, (2) reduction in HIV risk behaviors, and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity. DISCUSSION: This study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.

Nothing really changed: Arizona patient experience of methadone and buprenorphine access during COVID.

OBJECTIVE: To understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Managing acute opioid withdrawal with tramadol during COVID-19 lockdown in a peri-urban setting.

BACKGROUND: The coronavirus disease 2019 (COVID-19) has highlighted the scope of heroin dependence and need for evidence-based treatment amongst marginalised people in South Africa. Acute opioid withdrawal management without maintenance therapy carries risks of increased morbidity and mortality. Due to the high costs of methadone, Tshwane's Community Oriented Substance Use Programme (COSUP) used tramadol for opioid withdrawal management during the initial COVID-19 response. AIM: To describe demographics, route of heroin administration and medication-related experiences amongst people accessing tramadol for treatment of opioid withdrawal. SETTING: Three community-based COSUP sites in Mamelodi (Tshwane, South Africa). METHODS: A retrospective cross-sectional study was conducted. Data were collected using an interviewer-administered paper-based tool between April and August 2020. Descriptive statistics were used to analyse data. RESULTS: Of the 220 service users initiated onto tramadol, almost half (n = 104, 47%) were not contactable. Fifty-eight (26%) people participated, amongst whom most were male (n = 55, 95%). Participants' median age was 32 years. Most participants injected heroin (n = 36, 62.1%). Most participants experienced at least one side effect (n = 47, 81%) with 37 (64%) experiencing two or more side effects from tramadol. Insomnia occurred most frequently (n = 26, 45%). One person without a history of seizures experienced a seizure. Opioid withdrawal symptoms were experienced by 54 participants (93%) whilst taking tramadol. Over half (n = 38, 66%) reported using less heroin whilst on tramadol. CONCLUSION: Tramadol reduced heroin use but was associated with withdrawal symptoms and unfavourable side effects. Findings point to the limitations of tramadol as opioid withdrawal management to retain people in care and the importance of access to first-line opioid agonists.Contribution: This research contributes to the limited data around short-acting tramadol for opioid withdrawal management in the African context, with specific focus on the need for increased access to opioid agonists for those who need them, in primary care settings.

Receipt of Telehealth Services, Receipt and Retention of Medications for Opioid Use Disorder, and Medically Treated Overdose Among Medicare Beneficiaries Before and During the COVID-19 Pandemic.

Importance: Federal emergency authorities were invoked during the COVID-19 pandemic to expand use of telehealth for new and continued care, including provision of medications for opioid use disorder (MOUD). Objective: To examine receipt of telehealth services, MOUD (methadone, buprenorphine, and extended-release [ER] naltrexone) receipt and retention, and medically treated overdose before and during the COVID-19 pandemic. Design, Setting, and Participants: This exploratory longitudinal cohort study used data from the US Centers for Medicare & Medicaid Services from September 2018 to February 2021. Two cohorts (before COVID-19 pandemic from September 2018 to February 2020 and during COVID-19 pandemic from September 2019 to February 2021) of Medicare fee-for-service beneficiaries 18 years and older with an International Statistical Classification of Diseases, Tenth Revision, Clinical Modification OUD diagnosis. Exposures: Pre-COVID-19 pandemic vs COVID-19 pandemic cohort demographic characteristics, medical and substance use, and psychiatric comorbidities. Main Outcomes and Measures: Receipt and retention of MOUD, receipt of OUD and behavioral health-related telehealth services, and experiencing medically treated overdose. Results: The pre-COVID-19 pandemic cohort comprised 105 240 beneficiaries; of these, 61 152 (58.1%) were female, 71 152 (67.6%) were aged 45 to 74 years, and 82 822 (79.5%) non-Hispanic White. The COVID-19 pandemic cohort comprised 70 538 beneficiaries; of these, 40 257 (57.1%) were female, 46 793 (66.3%) were aged 45 to 74 years, and 55 510 (79.7%) were non-Hispanic White. During the study period, a larger percentage of beneficiaries in the pandemic cohort compared with the prepandemic cohort received OUD-related telehealth services (13 829 [19.6%] vs 593 [0.6%]; P < .001), behavioral health-related telehealth services (28 902 [41.0%] vs 1967 [1.9%]; P < .001), and MOUD (8854 [12.6%] vs 11 360 [10.8%]; P < .001). The percentage experiencing a medically treated overdose during the study period was similar (18.5% [19 491 of 105 240] in the prepandemic cohort vs 18.4% [13 004 of 70 538] in the pandemic cohort; P = .65). Receipt of OUD-related telehealth services in the pandemic cohort was associated with increased odds of MOUD retention (adjusted odds ratio [aOR], 1.27; 95% CI, 1.14-1.41) and lower odds of medically treated overdose (aOR, 0.67; 95% CI, 0.63-0.71). Among beneficiaries in the pandemic cohort, those receiving MOUD from opioid treatment programs only (aOR, 0.54; 95% CI, 0.47-0.63) and those receiving buprenorphine from pharmacies only (aOR, 0.91; 95% CI, 0.84-0.98) had lower odds of medically treated overdose compared with beneficiaries who did not receive MOUD. Conclusions and Relevance: Emergency authorities to expand use of telehealth and provide flexibilities for MOUD provision during the pandemic were used by Medicare beneficiaries initiating an episode of OUD-related care and were associated with improved retention in care and reduced odds of medically treated overdose. Strategies to expand provision of MOUD and increase retention in care are urgently needed.

Opioid agonist treatment take-home doses ('carries'): Are current guidelines resulting in low treatment coverage among high-risk populations in Canada and the USA?

Opioid agonist treatment (OAT) is the primary intervention for opioid use disorder (OUD) in Canada and the USA. Yet, a number of barriers contribute to sub-optimal treatment uptake and retention, including daily-supervised medication administration. Thus, clients are eventually granted access to take-home OAT doses (i.e., 'carries') to reduce this burden. However, this decision is based on physician discretion and whether patients can demonstrate stability in various life domains, many of which are inextricably linked to the social determinants of health (SDOH). Current Canadian and USA OAT carry guidance documents are not standardized and do not take the SDOH into consideration, resulting in the potential for inequitable access to OAT carries, which may be the case particularly among marginalized populations such as individuals with OUD who have been released from custody. This perspective article posits that current OAT guidelines contribute to inequities in access to OAT carries, and that these inequities likely result in disproportionately low coverage for OUD treatment among some high-risk groups, including individuals on release from incarceration in particular. Relevant impacts of COVID-19 and related policy changes are considered, and suggestions and recommendations to amend current OAT guidance documents are provided.