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Journal of Addiction MedicineThe purpose of this study was to examine the feasibility of implementing pre-exposure prophylaxis (PrEP), a daily oral medication for human immunodeficiency virus (HIV)...
OBJECTIVES
The purpose of this study was to examine the feasibility of implementing pre-exposure prophylaxis (PrEP), a daily oral medication for human immunodeficiency virus (HIV) prevention, in methadone clinics.
METHODS
Medical and nonmedical staff (n = 30) at 2 methadone clinics in Northern New Jersey were qualitatively interviewed about various aspects of substance use treatment, clinical operations, and HIV risk and prevention among their patient populations. Audio-recorded interviews were professionally transcribed, then coded and analyzed by the research team.
RESULTS
Themes surrounding the viability of PrEP implementation emerged for both logistical facilitators and barriers. Facilitators included availability of prescribing clinicians, ability to conduct lab testing on-site, and availability of existing hepatitis C programs as a blueprint for PrEP management. Barriers included increased provider burden, financial concerns, and perceptions that PrEP provision is outside the clinic's treatment scope.
CONCLUSIONS
Although staff expressed willingness and potential ability to provide PrEP, they identified barriers regarding insurance reimbursement, limited funding, and concerns that PrEP would extend the clinic's treatment scope. However, given the enabling factors such as availability of providers and existing clinical infrastructure, providing PrEP could increase clinic revenue through insurance reimbursement and federal funding for PrEP-related services. Clinic-level education is needed for clinical and nonclinical staff to better understand the logistics of implementing PrEP, particularly regarding prescribing practices, billing and insurance concerns, and the essential nature of HIV prevention as a critical component of substance use treatment.
Topics: Anti-HIV Agents; HIV Infections; Humans; Methadone; Pre-Exposure Prophylaxis
PubMed: 35165229
DOI: 10.1097/ADM.0000000000000973 -
PloS One 2022To understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic.
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.
Topics: Humans; Buprenorphine; Methadone; Opiate Substitution Treatment; Pandemics; Arizona; COVID-19; Opioid-Related Disorders; Patient Outcome Assessment; Analgesics, Opioid; COVID-19 Drug Treatment
PubMed: 36282806
DOI: 10.1371/journal.pone.0274094 -
Substance Abuse Treatment, Prevention,... Sep 2023The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment...
BACKGROUND
The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD.
METHODS
Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data.
RESULTS
Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients' cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists.
CONCLUSION
This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.
Topics: Humans; Pharmacies; Analgesics, Opioid; Pharmacists; Methadone; Pharmacy; Pharmaceutical Services; Pharmacy Administration; Opioid-Related Disorders
PubMed: 37697326
DOI: 10.1186/s13011-023-00563-w -
Addictive Behaviors Dec 2022Opioid use disorder (OUD) has been associated with the emergence of sleep disturbances. Although effective treatments for OUD exist, evidence suggests that these...
Opioid use disorder (OUD) has been associated with the emergence of sleep disturbances. Although effective treatments for OUD exist, evidence suggests that these treatments also may be associated with sleep impairment. The extent to which these effects are an effect of OUD treatment or a result of chronic opioid use remains unknown. We investigated the acute effects of methadone, buprenorphine, and naltrexone on actigraphy-based sleep-like parameters in non-opioid-dependent male rhesus monkeys (Macaca mulatta, n = 5). Subjects were fitted with actigraphy monitors attached to primate collars to measure sleep-like parameters. Actigraphy recordings were conducted under baseline conditions, or following acute injections of vehicle, methadone (0.03-1.0 mg/kg, i.m.), buprenorphine (0.01-1.0 mg/kg, i.m.), or naltrexone (0.03-1.0 mg/kg, i.m.) in the morning (4 h after "lights on") or in the evening (1.5 h before "lights off"). Morning and evening treatments with methadone or buprenorphine significantly increased sleep latency and decreased sleep efficiency. The effects of buprenorphine on sleep-like measures resulted in a biphasic dose-response function, with the highest doses not disrupting actigraphy-based sleep. Buprenorphine induced a much more robust increase in sleep latency and decrease in sleep efficiency compared to methadone, particularly with evening administration, and detrimental effects of buprenorphine on sleep-like measures were observed up to 25.5 h after drug injection. Treatment with naltrexone, on the other hand, significantly improved sleep-like measures, with evening treatments improving both sleep latency and sleep efficiency. The currently available pharmacotherapies for OUD significantly alter sleep-like parameters in non-opioid-dependent monkeys, and opioid-dependent mechanisms may play a significant role in sleep-wake regulation.
Topics: Actigraphy; Analgesics, Opioid; Animals; Buprenorphine; Humans; Macaca mulatta; Male; Methadone; Naltrexone; Opiate Substitution Treatment; Opioid-Related Disorders; Sleep
PubMed: 35901553
DOI: 10.1016/j.addbeh.2022.107433 -
Academic Emergency Medicine : Official... Aug 2022Medications for opioid use disorder (MOUD) prescribed in the emergency department (ED) have the potential to save lives and help people start and maintain recovery. We...
OBJECTIVES
Medications for opioid use disorder (MOUD) prescribed in the emergency department (ED) have the potential to save lives and help people start and maintain recovery. We sought to explore patient perspectives regarding the initiation of buprenorphine and methadone in the ED with the goal of improving interactions and fostering shared decision making (SDM) around these important treatment options.
METHODS
We conducted semistructured interviews with a purposeful sample of people with opioid use disorder (OUD) regarding ED visits and their experiences with MOUD. The interview guide was based on the Ottawa Decision Support Framework, a framework for examining decisional needs and tailoring decisional support, and the research team's experience with MOUD and SDM. Interviews were recorded, transcribed, and analyzed in an iterative process using both the Ottawa Framework and a social-ecological framework. Themes were identified and organized and implications for clinical care were noted and discussed.
RESULTS
Twenty-six participants were interviewed, seven in person in the ED and 19 via video conferencing software. The majority had tried both buprenorphine and methadone, and almost all had been in an ED for an issue related to opioid use. Participants reported social, pharmacological, and emotional factors that played into their decision making. Regarding buprenorphine, they noted advantages such as its efficacy and logistical ease and disadvantages such as the need to wait to start it (risk of precipitated withdrawal) and that one could not use other opioids while taking it. Additionally, participants felt that: (1) both buprenorphine and methadone should be offered; (2) because "one person's pro is another person's con," clinicians will need to understand the facets of the options; (3) clinicians will need to have these conversations without appearing judgmental; and (4) many patients may not be "ready" for MOUD, but it should still be offered.
CONCLUSIONS
Although participants were supportive of offering buprenorphine in the ED, many felt that methadone should also be offered. They felt that treatment should be tailored to an individual's needs and circumstances and clarified what factors might be important considerations for people with OUD.
Topics: Analgesics, Opioid; Buprenorphine; Emergency Service, Hospital; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders
PubMed: 35426962
DOI: 10.1111/acem.14507 -
Bulletin of the World Health... Jun 2021To assess the implementation of a mobile dispensing service to improve opioid users' access to methadone maintenance therapy.
OBJECTIVE
To assess the implementation of a mobile dispensing service to improve opioid users' access to methadone maintenance therapy.
METHODS
In March 2019, we started mobile methadone dispensing in an urban underprivileged locality in Delhi, India. The doctor was available only at the main community drug treatment clinic for clinical services, while the nurse dispensed methadone from a converted ambulance. We involved patients in identifying community leaders for sensitization and in deciding the location and timings for dispensing. We conducted a retrospective chart review of the programme data collected during delivery of clinical services. We compared the numbers of patients registered for methadone therapy and their retention and adherence to therapy in the 12-month periods before and after implementation of the mobile service.
FINDINGS
The number of patients registered for therapy at the clinic increased from 167 in the year before implementation to 671 in the year after. A significantly higher proportion of patients were retained in therapy at 3, 6 and 9 months after enrolment; 9-month retention rates were 19% (32/167 patients) and 45% (44/97 patients) in the year before and after implementation, respectively. There was no significant difference in patients' adherence to therapy between the two periods. Challenges included providing suitable dispensing hours for patients in employment and concerns of local community near to the dispensing sites.
CONCLUSION
It is feasible to dispense methadone by a mobile team in an urban setting, with better retention rates in therapy compared with dispensing through a stationary clinic.
Topics: Adult; Analgesics, Opioid; Female; Health Plan Implementation; Humans; India; Male; Methadone; Middle Aged; Mobile Health Units; Opiate Substitution Treatment; Opioid-Related Disorders; Program Evaluation; Retrospective Studies; Treatment Outcome
PubMed: 34108752
DOI: 10.2471/BLT.20.251983 -
Journal of Substance Use and Addiction... Sep 2023In response to the COVID-19 pandemic, countries across the world made adaptations to policies regulating the provision of methadone maintenance therapy (MMT) to... (Review)
Review
INTRODUCTION
In response to the COVID-19 pandemic, countries across the world made adaptations to policies regulating the provision of methadone maintenance therapy (MMT) to facilitate social distancing for health care providers and people in treatment. Many countries issued guidance about increasing take-home methadone doses after the onset of the pandemic.
METHODS
In this review, we compare the regulation of MMT prior to the pandemic in the United States, Canada, and Australia, analyze changes to treatment policy in the context of COVID-19, and review emerging data on treatment outcomes.
RESULTS
The United States only permits the prescription and disbursement of methadone for MMT treatment at federally designated opioid treatment programs (OTPs). Conversely, Australia and Canada operate on a community pharmacy-based distribution model, where patients can access methadone doses either in participating pharmacies or in some methadone clinics.
CONCLUSION
Given reports of similar treatment outcomes and increased patient satisfaction since the pandemic-related policy changes, some changes including increased receipt of take-home doses should be considered for incorporation into post-pandemic treatment policies and regulations.
Topics: Humans; United States; Opioid-Related Disorders; Pandemics; COVID-19; Opiate Substitution Treatment; Methadone; Canada; Australia
PubMed: 37270103
DOI: 10.1016/j.josat.2023.209086 -
BMC Health Services Research Nov 2022In 2019 daily liquid methadone and sublingual buprenorphine-naloxone were primary opioid agonist treatments for correctional centres in New South Wales, Australia....
BACKGROUND
In 2019 daily liquid methadone and sublingual buprenorphine-naloxone were primary opioid agonist treatments for correctional centres in New South Wales, Australia. However, both had significant potential for diversion to other patients, and their daily administration was resource intensive. An alternative treatment in the form of subcutaneous depot buprenorphine became a viable option following a safety trial in 2020 - the UNLOC-T study. Depot preparation demonstrated advantages over current treatments as more difficult to divert and requiring fewer administrations. This paper reports the results of economic modelling of staffing costs in medication administration comparing depot buprenorphine, methadone, and sublingual buprenorphine provision in UNLOC-T trial facilities.
METHODS
The costing study adopted a micro-costing approach involving the synthesis of cost data from the UNLOC-T clinical trial as well as data collected from Justice Health and Forensic Mental Health Network records. Labour and materials data were collected during site observations and interviews. Costs were calculated from two payer perspectives: a) the New South Wales (state) government which funds custodial and health services; and b) the Australian Commonwealth government, which pays for medications. The analysis compared the monthly-per-patient cost for each of the three medications in trial-site facilities during July 2019. This was followed by simulation of depot buprenorphine implementation across the study population. Costs associated with medical assessment and reviews were excluded.
RESULTS
The monthly-per-patient New South Wales government service costs of depot buprenorphine, methadone and sublingual buprenorphine were: $151, $379 and $1,529 respectively while Commonwealth government medication costs were $434, $80 and $525. The implementation simulation found that service costs of depot buprenorphine declined as patients transitioned from weekly to monthly administration. Costs of treatment using the other medications increased as patient numbers decreased alongside fixed costs. At 12 months, monthly-per-patient service costs for depot buprenorphine, methadone and sublingual buprenorphine-which would be completely phased out by month 13-were $92, $530 and $2,162 respectively.
CONCLUSIONS
Depot buprenorphine was consistently the least costly of the treatment options. Future modelling could allow for dynamic patient populations and downstream impacts for participants and the state health system.
TRIAL REGISTRATION
ACTRN12618000942257 . Registered 4 June 2018.
Topics: Humans; Buprenorphine; Analgesics, Opioid; Opioid-Related Disorders; New South Wales; Australia; Methadone
PubMed: 36348369
DOI: 10.1186/s12913-022-08687-8 -
Archives of Toxicology Aug 2022New approach methodologies predicting human cardiotoxicity are of interest to support or even replace in vivo-based drug safety testing. The present study presents an in...
New approach methodologies predicting human cardiotoxicity are of interest to support or even replace in vivo-based drug safety testing. The present study presents an in vitro-in silico approach to predict the effect of inter-individual and inter-ethnic kinetic variations in the cardiotoxicity of R- and S-methadone in the Caucasian and the Chinese population. In vitro cardiotoxicity data, and metabolic data obtained from two approaches, using either individual human liver microsomes or recombinant cytochrome P450 enzymes (rCYPs), were integrated with physiologically based kinetic (PBK) models and Monte Carlo simulations to predict inter-individual and inter-ethnic variations in methadone-induced cardiotoxicity. Chemical specific adjustment factors were defined and used to derive dose-response curves for the sensitive individuals. Our simulations indicated that Chinese are more sensitive towards methadone-induced cardiotoxicity with Margin of Safety values being generally two-fold lower than those for Caucasians for both methadone enantiomers. Individual PBK models using microsomes and PBK models using rCYPs combined with Monte Carlo simulations predicted similar inter-individual and inter-ethnic variations in methadone-induced cardiotoxicity. The present study illustrates how inter-individual and inter-ethnic variations in cardiotoxicity can be predicted by combining in vitro toxicity and metabolic data, PBK modelling and Monte Carlo simulations. The novel methodology can be used to enhance cardiac safety evaluations and risk assessment of chemicals.
Topics: Cardiotoxicity; Cytochrome P-450 Enzyme System; Humans; Kinetics; Methadone; Microsomes, Liver; Models, Biological
PubMed: 35604418
DOI: 10.1007/s00204-022-03309-y -
Drug and Alcohol Dependence Nov 2021The loosening of U.S. methadone regulations during the COVID-19 pandemic expanded calls for methadone reform. This study examines professional perceptions of methadone...
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.
Topics: COVID-19; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Pandemics; Perception; SARS-CoV-2
PubMed: 34600251
DOI: 10.1016/j.drugalcdep.2021.109100