Individualizing methadone treatment with split dosing: An underutilized tool.

Methadone's long half-life typically allows for once daily dosing. However, a growing body of evidence and clinical experience shows that some patients may benefit from twice-daily ("split") dosing to produce more stable symptoms and minimize side effects, independent of serum peak-to-trough levels. Concerns regarding split dosing typically center on diversion and poor adherence and must be taken seriously. However, policy changes during COVID-19 demonstrate that the rigidity historically applied to methadone may be unnecessarily stringent. Given clinical advances and policy updates, we believe clinicians should weigh the risks and benefits of this underutilized tool for select patients, as we await the evidence-based recommendations our patients deserve.

"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 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.

Feasibility of a Novel COVID-19 Telehealth Care Management Program Among Individuals Receiving Treatment for Opioid Use Disorder: Analysis of a Pilot Program.

BACKGROUND: The emergence of COVID-19 exacerbated the existing epidemic of opioid use disorder (OUD) across the United States due to the disruption of in-person treatment and support services. Increased use of technology including telehealth and the development of new partnerships may facilitate coordinated treatment interventions that comprehensively address the health and well-being of individuals with OUD. OBJECTIVE: The analysis of this pilot program aimed to determine the feasibility of delivering a COVID-19 telehealth care management program using SMS text messages for patients receiving OUD treatment. METHODS: Eligible individuals were identified from a statewide opioid treatment program (OTP) network. Those who screened positive for COVID-19 symptoms were invited to connect to care management through a secure SMS text message that was compliant with Health Insurance Portability and Accountability Act standards. Care management monitoring for COVID-19 was provided for a period of up to 14 days. Monitoring services consisted of daily SMS text messages from the care manager inquiring about the participant's physical health in relation to COVID-19 symptoms by confirming their temperature, if the participant was feeling worse since the prior day, and if the participant was experiencing symptoms such as coughing or shortness of breath. If COVID-19 symptoms worsened during this observation period, the care manager was instructed to refer participants to the hospital for acute care services. The feasibility of the telehealth care management intervention was assessed by the rates of adoption in terms of program enrollment, engagement as measured by the number of SMS text message responses per participant, and retention in terms of the number of days participants remained in the program. RESULTS: Between January and April 2021, OTP staff members referred 21 patients with COVID-19 symptoms, and 18 (82%) agreed to be contacted by a care manager. Participants ranged in age from 27 to 65 years and primarily identified as female (n=12, 67%) and White (n=15, 83%). The majority of participants were Medicaid recipients (n=14, 78%). There were no statistically significant differences in the demographic characteristics between those enrolled and not enrolled in the program. A total of 12 (67%) patients were enrolled in the program, with 2 (11%) opting out of SMS text message communication and choosing instead to speak with a care manager verbally by telephone. The remaining 10 participants answered a median of 7 (IQR 4-10) SMS text messages and were enrolled in the program for a median of 9 (IQR 7.5-12) days. No participants were referred for acute care services or hospitalized during program enrollment. CONCLUSIONS: These results demonstrate the feasibility of a novel telehealth intervention to monitor COVID-19 symptoms among OTP patients in treatment for OUD. Further research is needed to determine the applicability of this intervention to monitor patients with comorbid chronic conditions in addition to the acceptability among patients and providers using the SMS text messaging modality.

Latent COVID-19 Clusters in Patients with Opioid Misuse.

The goal of this paper is to apply unsupervised machine learning techniques in order to discover latent clusters in patients who have opioid misuse and also undergone COVID-19 testing. Target dataset has been constructed based on COVID-19 testing results at Mount Sinai Health System and opioid treatment program (OTP) information from New York State Office of Addiction Service and Support (OASAS). The dataset was preprocessed using factor analysis for mixed data (FAMD) method and then K-means algorithm along with elbow method were used to determine the number of optimal clusters. Four patient clusters were identified among which the fourth cluster constituted the maximum percentage of positive COVID-19 test results (20%). Compared to the other clusters, this cluster has the highest percentage of African Americans. This cluster has also the highest mortality rate (16.52%), hospitalization rate after receiving the COVID-19 test result (72.17%, use of ventilator (7.83%) and ICU admission rate (47.83%). In addition, this cluster has the highest percentage of patients with at least one chronic disease (99.13%) and age-adjusted comorbidity score more than 1 (83.48%). Longer participation in OTP was associated with the highest morbidity and mortality from COVID-19.

Sustainment of Contingency Management within Opioid Treatment Programs: COVID-Related Barriers and Innovative Workflow Adaptations.

Introduction: Contingency Management (CM) is one of the most effective interventions for persons with opioid use disorder, but one of the least available interventions in community settings, including opioid treatment programs. Project MIMIC is a NIDA-funded cluster randomized trial that is measuring CM implementation and sustainment across 30 opioid treatment programs in the New England region of the United States. The advent of the COVID-19 pandemic occurred in the midst of Project MIMIC's first cohort of eight opioid treatment programs, presenting a natural opportunity to document and analyze novel challenges to CM sustainment. Utilizing both quantitative and qualitative data collection, we aimed to identify both COVID-related barriers to CM sustainment and innovative workflow strategies to mitigate these barriers. Methods: Quantitative analysis was conducted using data collected from a study-specific CM tracker tool on various CM implementation metrics over three distinct, successive time intervals: prior to COVID-19 social distancing orders with active support; during COVID-19 social distancing orders with active support; and during COVID-19 social distancing orders after removal of support. Semi-structured qualitative interviews were conducted with a representative from each of the eight opioid treatment programs. Using a reflexive team approach, transcripts were coded by independent raters to identify both COVID-related barriers to sustainment and innovative workflow adaptations. Results: Quantitative data revealed a substantial decrease in the number of CM encounters following social distancing orders from 31.8 encounters weekly across eight programs to 6.9 encounters weekly across five programs. A further decline to 1.8 weekly encounters across three programs was observed after implementation support was removed. Four COVID-related barriers were identified via thematic analysis: fear of contagion; difficulty engaging patients remotely; challenges re-defining the CM attendance target due to changing regulations; and staff shortages. Potential adjustments discussed to help address one or more of these barriers included an electronic prize generator; use of technology to promote engagement; brief individual remote check-ins; and expansion of training to non-counseling staff. Conclusion: Although CM implementation challenges emerged during the pandemic, associated workflow adaptations also emerged. The feedback solicited in this study will inform multi-level strategies to aid with CM sustainment post-pandemic.

Treatment provider perceptions of take-home methadone regulation before and during COVID-19.

BACKGROUND: The loosening of U.S. methadone regulations during the COVID-19 pandemic expanded calls for methadone reform. This study examines professional perceptions of methadone take-home dose regulation before and during the COVID-19 pandemic to understand responses to varied methadone distribution policies. METHODS: Fifty-nine substance use disorder treatment professionals were interviewed between 2017 and 2020 in-person or over video call. An inductive iterative coding process was used to analyze the data. Constructivist grounded theory guided the collection and analysis of in-depth interviews. RESULTS: Treatment professionals expressed mixed views toward methadone take-home regulations. Participants justified regulation using several arguments: 1) patient care benefitting from supervision, 2) attributing improved patient safety to take-home regulation, 3) fearing liability for methadone-related harms, and 4) relying on buprenorphine as an "escape hatch" for patients who cannot manage MMT policies. Other professionals suggested partial deregulation, while others strongly opposed pre-pandemic take-home regulation, explaining such regulations impede medication access and hinder patient-centered care. Some professionals supported the COVID-19 policy changes and saw these as a test run for broader deregulation, while others framed the changes as temporary and cautiously applied deregulation to their services, at times revoking looser rules for patients they perceived as nonadherent. CONCLUSION: Treatment professionals working in a range of modalities, including opioid treatment programs, expressed hesitation toward expanded take-home methadone access. While some participants also supported forms of deregulation, post-pandemic efforts to extend looser methadone distribution policies will have to address apprehensive professionals if such policy changes are to be meaningfully adopted in community services.

Is necessity also the mother of implementation? COVID-19 and the implementation of evidence-based treatments for opioid use disorders.

Opioid-related overdoses and the coronavirus disease 2019 (COVID-19) represent two of the deadliest crises in United States' history and together constitute a syndemic. The intersecting risks of this syndemic underscore the urgent need to implement effective opioid use disorder (OUD) treatments that are sustainable amid COVID-19 mitigation strategies. In response to new federal guidance released during the pandemic, opioid treatment programs (OTPs) have quickly innovated to implement new systems of medication delivery. OTPs rapid implementation of new medication delivery models defies conventional wisdom about the pace of research transfer. As part of an ongoing cluster-randomized type 3 hybrid trial evaluating strategies to implement contingency management (CM), select staff of eight OTPs had been trained to deliver CM and were in the midst of receiving ongoing implementation support. As COVID-19 emerged, all eight OTPs mirrored trends in the addiction field and effectively adapted to federal/state demands to implement new methods of medication delivery. However, over the past few months, necessity has arguably been the mother of implementation. We have observed greater variance among these OTPs' success with the additional implementation of adjunctive CM. The speed and variability of innovation raises novel questions about drivers of implementation. We argue that the mother of the next innovation should be a public call for a progressive, thoughtful set of public health policies and other external setting levers to address the needs of those with OUD and the OTPs that serve them.