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Background: Regular counseling and frequent drug testing are common requirements for patients with opioid use disorder in buprenorphine treatment. State policies throughout the United States often reinforce these high-threshold practices, as was the case with Michigan, USA., Methods: We sought to explore the association between counseling requirements, drug testing practices, and buprenorphine treatment termination rates through administering a survey to buprenorphine prescribers in Michigan., Results: In our sample of 377 prescribers, we found associations between high-threshold practices like drug testing at every clinical visit and requiring counseling and buprenorphine treatment termination rates. Relative to prescribers who randomly drug tested, drug tested at fixed intervals, or did not require any drug testing, prescribers who drug-tested patients at every visit were 38% more likely to terminate treatment. Prescribers who required counseling were 33% more likely to terminate treatment than those who did not require counseling., Conclusion: With the elimination of the USA Drug Enforcement Administration X-waiver in December 2022, state policies need to minimize high-threshold practices that reduce buprenorphine treatment continuity and undermine an effective response to the overdose crisis., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Introduction: Medications for opioid use disorders (MOUD) remain the gold standard for treating OUD, but treatment initiation and adherence remain challenging. Exclusive utilization of pharmacotherapy as a treatment modality for OUD is sub-optimal, and a combination of psychotherapies and pharmacotherapies is recommended. General trends indicate the benefits of peer mentoring and MBRP separately. Therefore, we hypothesize that the combined effect of MBRP and Peer mentoring will produce synergistic improvements in MOUD adherence compared to an enhanced twelve-step facilitation (TSF). Methods: This paper describes the methods and baseline characteristics of a multi-site randomized controlled trial evaluating the effectiveness of a combination of MBRP and peer support (MiMP) compared to an enhanced TSF in improving adherence to MOUD. Both MiMP and TSF are 12-week manualized protocols that utilize licensed therapists. The interventions are delivered in weekly group sessions that last about 75-90 minutes per session. The primary outcome is MOUD adherence. Secondary and exploratory outcomes include relapse, cravings, depression, anxiety, stress, quality of life, and pain catastrophizing. Results: The participants' ages ranged from 21 years to 77 years, with a mean age of 44.5 (SD ± 11.5 years). There was an almost equal distribution of gender and place of residence. Overall, 51.9% (n=54) of participants identified as female and 48.1% (n=50) were male. Similarly, 51.9% (n=54) of participants resided in urban areas, while 48.1% (n=50) resided in rural areas. Participants identified as either black or white, with over three-quarters identifying as white (77.9%, n= 81) and 22.1% (n= 23) as black. Most participants randomized to the 12-step facilitation group were white (93.1%). Relationships and employment status were well distributed between categories. Over half of the participants reported some college or higher education. Over 90% of the participants made less than $75,000 per year. Some participants indicated that they had both public and private health insurance. Discussion and conclusion: This study is innovative in several ways including combining MBRP and peer support, addressing comorbid mental health issues among individuals with OUD, utilizing manualized protocols, and evaluating of both physiological and self-reported measures in assessing cortisol reactivity as a predictor of relapse and treatment outcomes. [ABSTRACT FROM AUTHOR]

The introduction of long‐acting injectable buprenorphine preparations for opioid use disorder has been widely heralded as a breakthrough treatment, with several studies indicating positive results when using these medications. In many locations, nurse practitioners prescribe, administer, and monitor long‐acting injectable preparations. The objective of this paper is to explore whether a reduction in dispensed needles and syringes is attributable to increased nurse practitioner prescribing of LAIB. We used a retrospective audit of needles dispensed through the health service needle and syringe program vending machine, and individuals treated with long‐acting injectable buprenorphine by the nurse practitioner led model. In addition, we examined potential factors that may influence changes in the number of needles dispensed. Linear regression found that each individual with opioid dependence treated with long‐acting injectable buprenorphine was associated with 90 fewer needles dispensed each month (p < 0.001). The nurse practitioner led model of care for individuals with opioid dependence appears to have influenced the number of needles dispensed at the needle and syringe program. Although all confounding factors could not be discounted entirely, such as substance availability, affordability, and individuals obtaining injecting equipment elsewhere, our research indicates that a nurse practitioner led model of treating individuals with opioid use disorder influenced needle and syringe dispensing in the study setting. [ABSTRACT FROM AUTHOR]

Cannabis misuse and opioid use disorder (OUD) are highly comorbid but under-treated and associated with poorer outcomes. This paper reports a double-blind, parallel-group randomized controlled trial to determine the efficacy of single-session, clinician-delivered screening and brief intervention (SBI) for reducing cannabis risk. The primary outcome was the cannabis-specific Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) scores, measured at three-month post-intervention. The secondary objectives were to determine the efficacy of SBI in reducing the frequency of cannabis use, in risk transition from moderate to low risk, and in prescription and non-prescription opioid use. One hundred forty-three participants were randomly allocated to receive either SBI (n = 72) or control (n = 71) interventions. We performed Per-protocol (PP) (n = 125) and Intention-to-treat (ITT) analysis (n = 143). We adjusted our analysis for age, sex, and baseline ASSIST score. The ITT showed that the SBI group had a significant reduction (F = 39.46, p < .001, Effect size 0.22) in the mean ASSIST at follow-up. PP analyses too revealed a similar positive effect of SBI (F = 53.1; p < .001, Effect size 0.31). At follow-up, the SBI group had a higher number of days of cannabis abstinence. Care providers and policymakers may consider SBI for cannabis use in individuals on medications for OUD.

Introduction: Monthly subcutaneous injectable buprenorphine (XR-Bup) is an option for treatment of opioid use disorder (OUD) that addresses some sublingual buprenorphine adherence barriers and is infrequently offered to hospitalized patients with OUD., Methods: A retrospective case series was performed for patients receiving XR-Bup upon discharge from 1 academic medical center. Demographic information, diagnoses, follow-up, and documented factors informing the selection of XR-Bup were extracted from the electronic health record., Results: In 1 year, 37 hospitalized patients with OUD received XR-Bup at discharge. The average age was 37.6 years, and patients were primarily Medicaid insured with an injection-related infection. The most common documented factors informing the selection of XR-Bup were as follows: previous sublingual buprenorphine adherence barriers, concurrent stimulant use disorder, and patient preference. Sixty-four percent of patients scheduled for follow-up attended appointments, and 55% received a second dose of XR-Bup., Conclusions: Subcutaneous injectable buprenorphine is an option for OUD treatment among hospitalized patients providing 30 or more days of buprenorphine coverage in the postdischarge period., Competing Interests: MRL has been a scientific consultant for medications and devices in development (unrelated to this paper) for Titan Pharmaceuticals, Berkshire Biomedical, Braeburn, and Journey Colab. The other authors report no conflicts of interest., (Copyright © 2023 American Society of Addiction Medicine.)

Background: Conceptualisations of the 'patient journey' are popular within health service research. Patient journeys provide a person-centred approach to health care that typically prioritise subjective patient experience with the aim of improving relevant forms of intervention. This article explores the conceptualisation of retention in treatment for opioid use disorder (OUD) using long-acting injectable buprenorphine (LAIB) as a journey., Methods: Data derive from a longitudinal qualitative study, involving semi-structured interviews (held at six time-points), with participants who each initiated LAIB for the first time. Data analysis for this article focuses exclusively upon the experiences of those who had continued with LAIB treatment throughout one year (11 participants). Framework and thematic narrative analyses of 64 interviews with 11 participants sought to identify 'retention-narratives' that would indicate a 'retention journey' associated with LAIB treatment., Findings: Shared treatment experiences consisted of three distinct phases (Withdrawal and Separation, Transformation, and Engagement) that progressed in a linear and intersecting manner through time. Each phase had features that defined treatment experiences at a given time but changed as treatment progressed. All 11 participants experienced multiple features within each of the three treatment phases and all participants reported separation from their respective service provider throughout the first 12 months of treatment. Although some valued the latter separation, most were dissatisfied by reduced levels of contact., Conclusion: Retention in treatment for OUD with LAIB, for at least 12-months, can be conceptualised as a journey. This conceptualisation emphasises the benefits (and challenges) clinicians and patients may expect to encounter during the first year of a LAIB treatment programme. An added implication of conceptualising LAIB treatment in this manner is that optimal benefits of the medication (as observed by participants) began to emerge during 'months 7-12' of the retention journey., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Within the national opioid epidemic, there has been an increase in the number of infants exposed to opioids in utero. Additionally, opioid agonist medications are the standard of care for women with opioid use disorder during pregnancy. Buprenorphine (BUP), a partial µ -opioid receptor agonist, has been successful in improving gestational and neonatal outcomes. However, in utero exposure has been linked to childhood cognitive and behavioral problems. Therefore, we sought to compare offspring cognitive and behavioral outcomes after prenatal exposure to a clinically relevant low dose of BUP compared to morphine (MO), a full µ -opioid receptor agonist and immediate metabolite of heroin. We used a mouse model to assess gestational and offspring outcomes. Mouse dams were injected once daily s.c. with saline (SAL, n = 12), MO (10 mg/kg, n = 15), or BUP (0.1 mg/kg, n = 16) throughout pre-gestation, gestation, and lactation until offspring were weaned on postnatal day (P)21. Offspring social interaction and exploratory behavior were assessed, along with executive function via the touchscreen 5 choice serial reaction time task (5CSRTT). We then quantified P1 brain gene expression in the frontal cortex and amygdala (AMG). Perinatal MO but not BUP exposure decreased gestational weight gain and was associated with dystocia. In adolescent offspring, perinatal MO but not BUP exposure increased social exploration in males and grooming behavior in females. In the 5CSRTT, male MO exposed offspring exhibited increased impulsive action errors compared to male BUP offspring. In the AMG of P1 MO exposed offspring, we observed an increase in gene expression of targets related to activity of microglia. Importantly, both MO and BUP caused acute hyperlocomotion in the dams to a similar degree, indicating that the selected doses are comparable, in accordance with previous dose comparisons on analgesic and reward efficacy. These data suggest that compared to MO, low dose BUP improves gestational outcomes and has less of an effect on the neonatal offspring brain and later adolescent and adult behavior., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Expanding access to opioid use disorder (OUD) treatment, including methadone, is imperative to address the US overdose crisis. In June 2021, the Drug Enforcement Administration announced new regulations allowing all opioid treatment programs (OTPs) to deploy mobile medication units, or methadone vans, to dispense OUD medication treatment outside of clinic walls, ending a 13-year moratorium. We conducted a qualitative study evaluating one opioid treatment program's experience, including benefits and challenges with implementing a methadone van, to inform future policy and clinical practice., Methods: We recruited staff and patients receiving OUD medication treatment from an OTP in San Francisco, CA. The OTP had one operating van before March 2020 and began operating an additional van in response to COVID-19-related efforts to de-populate clinic settings. We interviewed 10 providers and 20 patients from August to November 2020. We transcribed, coded, and analyzed all interviews using modified grounded theory methodologies., Results: Both patients and providers perceived significant benefits with receiving OUD medications using methadone vans. Patients preferred dosing at the van over the clinic because they were able to "get in and out" faster. Both staff and patients appreciated being able to use phone counseling to connect with counselors which helped reduce in-person visits and streamline workflows. Providers also noted van implementation challenges, including daily van set up, urine drug testing, and delivering counseling to patients who lacked phones., Conclusions: Eased restrictions on methadone van implementation represent a new strategy for expanding OUD treatment access. In our qualitative study, patients and staff were satisfied with methadone van implementation, though the OTP still faced implementation challenges. Audio-only counseling and other workflow solutions helped facilitate implementation, and several policy considerations like maintaining audio-only counseling flexibilities are key to ensuring future van success. Methadone vans offer the potential to expand treatment uptake, while prioritizing patient-centered care., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Over the past decade, hospitals and health systems have increasingly adopted interventions to address the needs of patients with substance use disorders. The Opioid Use Disorder (OUD) Cascade of Care provides a framework for organizing and tracking patient health milestones over time and can assist health systems in identifying areas of intervention to maximize the impact of evidence-based services. However, detailed protocols are needed to guide health systems in how to operationalize the OUD Cascade and track outcomes using electronic health records. Objective: In this paper, we describe the process of operationalizing and applying the OUD Cascade in a large, urban, public hospital system. Methods: Through this case example, we describe the technical processes around data mining, as well as the decision-making processes, challenges encountered, lessons learned from compiling preliminary patient data and defining stages and outcome measures for the OUD Cascade of Care, and preliminary data Results: We identified 33,616 (26.17% female) individuals with an OUD diagnosis. Almost half (48%) engaged with addiction services, while only 10.7% initiated medication-based treatment in an outpatient setting, 6.7% had timely follow-up, and 3.5% were retained for a minimum of 6 months. Conclusion: The current paper serves as a primer for other health systems seeking to implement data-informed approaches to guide more efficient care and improved substance use-related outcomes. An OUD Cascade of Care must be tailored to local systems based on inherent data limitations and services design with an emphasis on early stages wherein drop-off is the greatest. [ABSTRACT FROM AUTHOR]

Drug consumption in prisons is a concern for the safety of incarcerated people and staff. Typically, drug use prevalence in prisons is estimated through urinalysis and intelligence operations, which can be intrusive and stressful. An alternative approach, wastewater-based epidemiology (WBE), was used in this study to estimate the consumption of licit and illicit drugs for the entire population of a prison in Australia. Wastewater samples were collected from March to December 2020, covering periods of no restrictions and periods when prison access was restricted to prevent the transmission of COVID-19. Target biomarkers were analysed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The average consumption of common illicit drugs (MDMA, methamphetamine and cocaine) over the sampling period in the prison (0.5 - 4.5 mg/1000 people/day) was two to three orders of magnitude lower than in the community population (254 - 1000 mg/1000 people/day). Comparison of WBE estimates against pharmacy dispensing data suggested potential illicit buprenorphine consumption at the prison. Methamphetamine and buprenorphine use decreased when no visitors were allowed (18% - 72% decrease for methamphetamine; about half decrease for buprenorphine) and increased once these restrictions were eased (22% - 39% increase for methamphetamine; 44% - 67% increase for buprenorphine). The changes in drug use may be attributed in part to a reduction of drug trafficking into the prison from visitors or non-essential staffs and in part to the reduced contribution of urine from staff who used toilets within the prison. This study provided useful information on the scale of illicit drug use and extra-medical use of licit drugs in prison, and its changes under different security conditions., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Ltd.)

Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Fernald et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Tapentadol is an atypical opioid analgesic thought to have dual mechanisms of action: µ-receptor agonism and inhibition of norepinephrine reuptake. Unlike other atypical opioids, tapentadol is a schedule II-controlled substance. We compared the prevalence of abuse (use to get high) of tapentadol to other atypical opioids used to treat pain (buprenor-phine and tramadol)., Design: An observational, serial cross-sectional study., Setting: Individuals enrolling in treatment programs for opioid use disorder in 2019. Each completed a self-administered, paper questionnaire assessing prescription drug abuse and illegal drug use within 1 week of enrollment., Main Outcome Measures: Indication of past month abuse of tapentadol or comparator drugs on a self-administered ques-tionnaire., Results: There were 6,987 respondents. Unadjusted and utilization-adjusted logistic regression models were used to compare odds of endorsement of tapentadol to tramadol and buprenorphine products indicated for the management of pain. Unadjusted abuse prevalence was 0.20 percent for total tapentadol (0.03 percent for NUCYNTA® and 0.06 percent for NUCYNTA ER). Relative to total tapentadol, the odds of abuse of buprenorphine for pain was 2.9 times greater (95 percent CI: 1.6 to 5.3, p < 0.001), and for tramadol, 43.1 times greater (95 percent CI: 25.3 to 73.3, p < 0.001). Adjusting for prescriptions dispensed, differences in odds of abuse were not statistically significant (odds ratio (OR) = 1.6, 95 per-cent CI: 0.9 to 3.0, p = 0.108 for buprenorphine for pain and OR = 0.7, 95 percent CI: 0.4 to 1.2, p = 0.209 for tramadol)., Conclusions: Tapentadol use to get high is less frequent than other atypical opioids. Findings suggest tapentadol is rarely the primary drug abused by an individual.

Background: Sleep disturbances are seen even in individuals on opioid agonist treatment (OAT). Established pharmacotherapy for sleep disturbances such as benzodiazepines have misuse potential and increased mortality risk in patients with OAT. No study has explored the role of trazodone on sleep disturbance in individuals maintained on buprenorphine. We aimed to assess the efficacy of trazodone in improving sleep disturbance among individuals maintained on buprenorphine., Methods: The study was a double-blind, placebo-controlled, parallel, randomised trial. Adult males (18-60 years) stabilised on buprenorphine with Pittsburgh Sleep Quality Index (PSQI) score of above five, without other psychiatric comorbidity were randomised to receive either trazodone (50-150mg per day) or placebo. Sleep-50 questionnaire, Epworth Sleepiness Scale (ESS), Brief Pain Inventory (BPI), Clinical Opiate Withdrawal Scale (COWS), Depression, Anxiety and Stress Scale (DASS)-21, Visual Analogue Scale (VAS) for opioid craving, and PSQI were assessed at baseline and at the end of six weeks., Results: Fifty-one patients were allocated to trazodone arm and 49 to placebo arm. Side-effects of trazodone were minimal and well-tolerated with comparable discontiuation rates between both groups. Significantly greater proportion of patients on trazodone (82%, mean dose 101.9 mg) had PSQI scores five or less than those on placebo (16%) at the end of six weeks. Sleep improvement was in various components like sleep quality, latency, efficiency, and duration of sleep., Conclusion: Trazodone is well-tolerated and effective in improving sleep disturbances in individuals with opioid dependence maintained on buprenorphine over a six-week period., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Background: Medication for opioid use disorder (MOUD) is an effective intervention to combat opioid use disorder and overdose, yet there is limited understanding of engagement in treatment over time in the community, contextualized by ongoing substance use. We aimed to identify concurrent trajectories of methadone prescriptions, buprenorphine prescriptions, and illicit opioid use among older adults with a history of injection drug use., Methods: We used data on 887 participants from the AIDS Linked to the IntraVenous Experience cohort, who were engaged in the study in 2013 and attended ≥1 visit during follow-up (2014-2019). Outcomes were self-reported MOUD prescription and illicit opioid use in the last 6 months. To identify concurrent trajectories in all 3 outcomes, we used group-based multi-trajectory modeling. We examined participant characteristics, including sociodemographics, HIV status, and other substance use, overall and by cluster., Results: We identified 4 trajectory clusters: (1) no MOUD and no illicit opioid use (43%); (2) buprenorphine and some illicit opioid use (11%); (3) methadone and no illicit opioid use (28%); and (4) some methadone and illicit opioid use (18%). While prevalence of each outcome was stable across time, transitions on/off treatment or on/off illicit opioid use occurred, with the rate of transition varying by cluster. The rate of transition was highest in Cluster 3 (0.74/person-year) and lowest in Cluster 1 (0.18/person-year). We saw differences in participant characteristics by cluster, including that the buprenorphine cluster had the highest proportion of people with HIV and participants who identified as non-Hispanic Black., Conclusions: Most participants had discontinued illicit opioid use and were also not accessing MOUD. Trajectories defined by engagement with buprenorphine or methadone had distinct sociodemographic and behavioral characteristics, indicating that tailored interventions to expand access to both types of treatment are likely needed to reduce harms associated with untreated opioid use disorder., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background and Aims: Long-acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that is generating positive outcomes. Negative effects are typically mild and transient, but can occasionally be serious, resulting in treatment discontinuation/non-adherence. This paper aims to analyse patients' accounts of how they felt during the first 72 h after initiating LAIB., Methods: Semi-structured interviews were conducted (June 2021-March 2022) with 26 people (18 males and 8 females) who had started LAIB within the previous 72 h. Participants were recruited from treatment services in England and Wales and were interviewed by telephone using a topic guide. Interviews were audio-recorded, transcribed and coded. The concepts of embodiment and embodied cognition framed the analyses. Data on participants' substance use, initiation onto LAIB and feelings were tabulated. Next, participants' accounts of how they felt were analysed following the stages of Iterative Categorization., Results: Participants reported complex combinations of changing negative and positive feelings. Bodily experiences included withdrawal symptoms, poor sleep, injection-site pain/soreness, lethargy and heightened senses inducing nausea ('distressed bodies'), but also enhanced somatic wellbeing, improved sleep, better skin, increased appetite, reduced constipation and heightened senses inducing pleasure ('returning body functions'). Cognitive responses included anxiety, uncertainties and low mood/depression ('the mind in crisis') and improved mood, greater positivity and reduced craving ('feeling psychologically better'). Whereas most negative effects reported are widely recognized, the early benefits of treatment described are less well-documented and may be an overlooked distinctive feature of LAIB., Conclusions: During the first 72 h after initiating long-acting injectable buprenorphine, new patients report experiencing a range of interconnected positive and negative short-term effects. Providing new patients with information about the range and nature of these effects can prepare them for what to expect and help them manage feelings and reduce anxiety. In turn, this may increase medication adherence., (© 2023 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Caring for pregnant women who have a recreational opioid use disorder is a common clinical challenge in modern obstetric care. These are an elusive population who often have multiple social issues that complicate their pregnancy management. Comprehensive and supportive maternal care can motivate these mothers to change her lifestyle. Multidisciplinary non-judgemental approach with appropriate medication and management, can result in good pregnancy outcomes for mother and her baby., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

The Russian invasion of Ukraine in February 2022 caused major disruptions of societal functions, including health care. Patients receiving medications for opioid use disorder (MOUD) depend on receiving daily treatment and face a risk of withdrawal in case of medication supply disruption. MOUD are banned in Russia, making treatment continuation impossible in temporarily occupied areas. In this paper, we review the situation with MOUD delivery in Ukraine during the first year of the Russia-Ukraine war. Legislative changes and mobilization of efforts in the time of crisis ensured treatment continuation for thousands of patients. In areas controlled by Ukraine, most patients were receiving take-home doses for up to 30 days, some experienced temporary dosing reductions. Programs in temporarily occupied regions were shut down likely leading to abrupt withdrawal among many patients. At least 10% of patients have been internally displaced. One year into the war, the number of MOUD patients in governmental clinics of Ukraine increased by 17%, and the data suggest that the coverage of private clinics has also increased. But the risks for program stability remain high as the current medication supply relies on one manufacturing facility. Using lessons learned from the crisis, we provide recommendations for future response to minimize the risks of major adverse outcomes among patients treated for opioid use disorder., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: Persons with opioid use disorder (OUD) suffer disproportionately from morbidity and mortality related to serious addiction-related infections requiring hospitalization. Long-acting buprenorphine (LAB) is an underused medication for OUD that may facilitate linkage to care and treatment retention when administered before hospital discharge. Transition onto buprenorphine in the inpatient setting is often complicated by pain, active infection management, potential surgical interventions, and risk of opioid withdrawal in transition from full agonists to a partial agonist., Methods: The COMMIT Trial is a randomized controlled trial evaluating LAB administered by infectious disease physicians and hospitalists compared with treatment as usual for persons with OUD hospitalized with infections. We report a case series of participants on full agonist opioids including methadone who were transitioned to sublingual buprenorphine using low-dose ( microdosing ) strategies followed by LAB injection., Results: Seven participants with current opioid use disorder and life-threatening infections, all with significant concurrent pain and many requiring surgical intervention, underwent low-dose transitions starting at buccal buprenorphine doses ranging from 225 μg to 300 μg 3 times a day on the first day. All were well tolerated with average time to LAB injection of 7.5 days (range, 5-10 days)., Conclusions: Inpatient low-dose buprenorphine transition from full agonist opioids including methadone onto LAB is feasible even in those with complex hospitalizations for concurrent infections and/or surgery. This strategy facilitates dosing of LAB before hospital discharge when risk of opioid relapse and overdose are significant., Competing Interests: Dr Springer has provided scientific consultation to Alkermes Inc and received NIH and VA grant funding. She has received in-kind study drug donations from Alkermes Inc and Indivior Pharmaceutical Company for NIH-funded research. Dr Levin receives grant support from the NIDA, SAMHSA, and from Aelis Pharmaceuticals. She also receives medication from Indivior for research. In addition, she served as a nonpaid member of a Scientific Advisory Board for Alkermes, Indivior, Novartis, Teva, and US WorldMeds and is a consultant to Major League Baseball. Dr Brady has provided scientific consultation to Alkermes, Indivior, Sage, and Jazz Pharmaceuticals. She has received grant funding from NIH and in-kind study drug from US World Meds. Dr Nunes has served as a consultant without compensation for Alkermes, Camurus, Indivior, and Pear Therapeutics and received in-kind study drug or digital therapeutic donations for NIH funded studies from Alkermes, Indivior, Braeburn-Camurus, Pear Therapeutics, and CHESS Health. Dr Litwin has served as on advisory boards with Gilead Sciences and AbbVie, and has received research grants from NIDA, NSF, SAMHSA, HRSA, and Gilead Sciences. The authors alone are responsible for the content and writing of this paper. No conflicts of interest declared for the remaining authors., (Copyright © 2023 American Society of Addiction Medicine.)

Background: Long-acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that has been introduced against an international policy backdrop of recovery and person-centred care. This paper explores the goals that people want to achieve from LAIB to identify potential implications for policy and practice., Methods: Data derive from longitudinal qualitative interviews conducted with 26 people (18 male; 8 female) initiating LAIB in England and Wales, UK (June 2021-March 2022). Participants were interviewed up to five times by telephone over six months (107 interviews in total). Transcribed interview data relating to each participant's treatment goals were coded, summarised in Excel, and then analysed via a process of Iterative Categorization., Results: Participants often articulated a desire to be abstinent without defining exactly what they meant by this. Most intended to reduce their dosage of LAIB but did not want to rush. Although participants seldom used the term 'recovery', almost all identified objectives consistent with current definitions of this concept. Participants articulated broadly consistent goals over time, although some extended the timeframes for achieving treatment-related goals at later interviews. At their last interview, most participants remained on LAIB, and there were reports that the medication was enabling positive outcomes. Despite this, participants were aware of the complex personal, service-level, and situational factors that hindered their treatment progress, understood the additional support they needed to achieve their goals, and voiced frustrations when services failed them., Conclusions: There is a need for wider debate regarding the goals people initiating LAIB are seeking and the diverse range of positive treatment outcomes LAIB could potentially generate. Those providing LAIB should offer regular on-going contact and other forms of non-medical support so that patients have the best opportunity to succeed. Policies relating to recovery and person-centred care have previously been criticised for responsibilising patients and service users to take better care of themselves and to change their own lives. In contrast, our findings suggest that these policies may, in fact, be empowering people to expect a greater range of support as part of the package of care they receive from service providers., (© 2023. The Author(s).)

Background: Epidemic increases in opioid deaths prompted policies limiting access to prescription opioids in North America. Consequently, the over-the-counter opioids loperamide (Imodium A-D) and mitragynine, the herbal ingredient in kratom, are increasingly used to avert withdrawal or induce euphoria. Arrhythmia events related to these nonscheduled drugs have not been systematically studied., Objectives: In this study, we sought to explore opioid-associated arrhythmia reporting in North America., Methods: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), and Canada Vigilance Adverse Reaction (CVAR) databases were searched (2015-2021). Reports involving nonprescription drugs (loperamide, mitragynine) and diphenoxylate/atropine (Lomotil) were identified. Methadone, a prescription opioid (full agonist), served as a positive control owing to its established arrhythmia risk. Buprenorphine (partial agonist) and naltrexone (pure antagonist), served as negative controls. Reports were classified according to Medical Dictionary for Regulatory Activities terminology. Significant disproportionate reporting required a proportional reporting ratio (PRR) of ≥2, ≥3 cases, and chi-square ≥4. Primary analysis used FAERS data, whereas CAERS and CVAR data were confirmatory., Results: Methadone was disproportionately associated with ventricular arrhythmia reports (PRR: 6.6; 95% CI: 6.2-7.0; n = 1,163; chi-square = 5,456), including 852 (73%) fatalities. Loperamide was also significantly associated with arrhythmia (PRR: 3.2; 95% CI: 3.0-3.4; n = 1,008; chi-square = 1,537), including 371 (37%) deaths. Mitragynine demonstrated the highest signal (PRR: 8.9; 95% CI: 6.7-11.7; n = 46; chi-square = 315), with 42 (91%) deaths. Buprenorphine, diphenoxylate, and naltrexone were not associated with arrhythmia. Signals were similar in CVAR and CAERS., Conclusions: The nonprescription drugs loperamide and mitragynine are associated with disproportionate reports of life-threatening ventricular arrhythmia in North America., Competing Interests: Funding Support and Author Disclosures This publication reflects independent work of the authors and is not a representation of official policies or positions of the American College of Cardiology or any U.S. governmental agency, including the Department of Defense, Veterans Medical Affairs Medical Center, or the Food and Drug Administration. Dr Kao was supported by K08 HL125725. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: The objective of this study is to explore pregnant and postpartum individuals' knowledge, attitudes, and perceptions regarding extended-release buprenorphine (XR-BUP) treatment for opioid use disorder., Methods: We conducted a paper-based survey of pregnant or postpartum individuals with opioid use disorder attending a multidisciplinary perinatal addiction specialty care clinic where XR-BUP is available. Participants' nonidentifiable demographic and treatment characteristics were collected, including duration and satisfaction of current medication for opioid use disorder. Participants' knowledge, attitudes, and perceptions about XR-BUP were assessed using a 5-point Likert scale. Descriptive statistics were used to summarize the data., Results: From February 2021 to August 2021, 79 of 98 eligible participants completed the survey (81% response rate). More than 9 of 10 participants were currently taking medication for opioid use disorder, and 7 individuals (8.9%) were taking XR-BUP. Nearly half (49.4%) had never heard of XR-BUP, and 84.8% did not personally know anyone taking XR-BUP. However, 45.6% and 29.1% would consider an injectable medication for opioid use disorder to avoid trouble remembering to take their daily medications and avoid opioid withdrawal symptoms, respectfully., Conclusions: In a population of pregnant and postpartum individuals, nearly half were unaware of a monthly XR-BUP option for the treatment of opioid use disorder. Many were interested in considering this medication. Future studies are needed to rigorously assess outcomes associated with XR-BUP among pregnant and postpartum individuals with opioid use disorder., Competing Interests: Dr. Smid serves as a medical consultant for Gilead Science Incorporated and Organon Incorporated. Dr. Smid also receives funding from NIDA and the CDC. The other authors have no conflicts of interest to disclose., (Copyright © 2022 American Society of Addiction Medicine.)

Background: Depressive symptoms are common in patients seeking medication treatment for opioid use disorder (MOUD treatment) and decrease quality of life but have been inconsistently related to opioid treatment outcomes. Here, we explore whether depressive symptoms may only be related to adverse treatment outcomes among individuals reporting high opioid use-related coping motives (i.e., use of opioids to change affective states) and high trait impulsivity, two common treatment targets., Methods: Patients seeking MOUD treatment (N = 118) completed several questionnaires within two weeks of their treatment intake. Treatment outcomes (opioid-positive urine screens and days retained in treatment) were extracted from treatment records. Moderation analyses controlling for demographic characteristics and main effects were conducted to explore interaction effects between depressive symptoms and two distinct moderators., Results: Depressive symptoms were only related to opioid use during early treatment among patients reporting high opioid use-related coping motives (B = 2.67, p =.004) and patients reporting high trait impulsivity (B = 2.01, p =.039). Further, depressive symptoms were only inversely related to days retained among individuals with high opioid use-related coping motives (B = -10.12, p =.003)., Conclusions: Individuals presenting to treatment with opioid-related coping motives and/or impulsivity in the context of depressive symptoms may confer unique risk for adverse treatment outcomes. Clinicians may wish to consider these additive risk factors when developing their treatment plan., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: Long-acting injectable depot buprenorphine is a recent addition to the suite of opioid agonist therapies (OAT) used to treat opioid use disorder (OUD). However, there has been little research that focuses on the lived experience of people receiving depot buprenorphine treatment and reasons for why people decide to discontinue. The aim of this study was to explore what it is like to receive depot buprenorphine and to understand the motivations behind why people discontinue., Methods: Open-ended, semi-structured interviews were conducted between November 2021 and January 2022 with individuals who were either currently receiving depot buprenorphine or had discontinued or were in the process of discontinuing depot buprenorphine. Liberati, et al.'s (2022) adaptation of Dixon-Woods's (2006) candidacy framework was used to analyse the participant experiences., Results: 40 participants (26 male, 13 female, 1 undisclosed; mean age 42 years) were interviewed about their experience with depot buprenorphine. At the time of the interview, 21 were currently receiving depot buprenorphine and 19 had discontinued this treatment or were in the process of discontinuing. Participants cited 4 key reasons why they decided to discontinue depot buprenorphine:1) feeling forced into the program, 2) experiencing negative side-effects, 3) finding the treatment ineffective, and 4) wanting to stop depot buprenorphine/OAT to use opioids again or feeling 'cured' and no longer in need of OAT. Participants were ultimately discussing issues related to clinician-patient power relations, agency and bodily autonomy, and the pursuit of well-being., Conclusion: Depot buprenorphine remains a promising treatment for OUD and offers potential to improve treatment adherence. Instances of restricted OAT choice and consumer concerns regarding a lack of agency must be addressed in order to enhance therapeutic relationships. Clinicians and other healthcare workers in this field also need greater access to information about depot buprenorphine to better address issues patients face during treatment. More research is required to understand patient and treatment choice given the options of these new treatment formulations., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

Stigma toward people taking medication for opioid use disorder (MOUD) is prevalent, harmful to the health and well-being of this population, and impedes MOUD treatment resource provision, help-seeking, and engagement in care. In recent years, clinicians have implemented new models of MOUD-based treatment in parts of the United States that integrate buprenorphine initiation into emergency departments and other acute general medical settings, with post-discharge linkage to office-based treatment. These service models increase access to MOUD and they have potential to mitigate stigma toward opioid use and MOUD. However, the empirical literature connecting these emerging service delivery models to stigma outcomes remains underdeveloped. This paper aims to bridge the stigma and health service literatures via a conceptual model delineating how elements of emerging MOUD service models can reduce stigma and increase behavior in pursuit of life goals. Specifically, we outline how new approaches to three key processes can counter structural, public, and self-stigma for this population: (1) community outreach with peer-to-peer influence, (2) clinical evaluation and induction of MOUD in acute care settings, and (3) transition to outpatient maintenance care and early recovery. Emerging service models that target these three processes can, in turn, foster patient empowerment and pursuit of life goals. There is great potential to increase the well-being of people who use opioids by reducing stigma against MOUD via these structural changes. [ABSTRACT FROM AUTHOR]

Transdermal delivery is a non-invasive route, used as an alternative to the oral route, to administer drugs through the skin surface. One of the fields in which they are particularly used is that of pain therapy. In this treatment, transdermal patches, particularly those containing opioids, are used to complement or replace orally administered drugs. First-generation patches are constituted by reservoir systems, where the drug is dissolved in a solvent and gelled with a polymer. In contrast, the active principle is incorporated into the polymer adhesive in more recent matrix patches. In this review, the main papers related to the production and employment of transdermal patches containing the two most used opioids, i.e., fentanyl and buprenorphine, have been critically analyzed. From the analysis of the literature, it is possible to deduce that the type of drug and the amount of drug present in the patch must be chosen not according to the origin of the pain but to the age of the patient, the area where the patch is applied, and the frequency at which the patch is replaced. [ABSTRACT FROM AUTHOR]

Introduction: With the increasing use of non-prescribed buprenorphine (NPB), we need more data to identify the longitudinal patterns of NPB use. The goal of this natural history study is to characterize heterogeneity in trajectories of NPB, other opioid use, and participation in medication for opioid disorder (MOUD) treatment among a community-recruited sample of individuals with current opioid use disorder (OUD)., Methods: The study recruited a community-based sample of 357 individuals with OUD who used NPB in the past 6 months in Ohio, United States, for baseline and follow-up assessments (every 6 months for 2 years) of drug use, treatment participation, and other health and psychosocial characteristics. The study used multiple imputation to handle missing data. We used a multi-trajectory latent class growth analysis (MT-LCGA) to find salient groupings of participants based on the trajectories of NPB, other opioid use, and treatment participation., Results: Over time, NPB use frequency declined from a mean of 14.6 % of days at baseline to 3.6 % of days at 24-month follow-up along with declines in heroin/fentanyl (56.4 % to 23.6 % of days) and non-prescribed pharmaceutical opioid (NPPO) use (11.6 % to 1.5 % of days). Participation in MOUD treatment increased from a mean of 17.0 % of days at baseline to 52.4 % of days at 24 months. MT-LCGA identified a 6-class model. All six classes showed declines in NPB use. Class 1 (28 %) was characterized by high and increasing MOUD treatment utilization. Class 2 (21 %) showed sustained high levels of heroin/fentanyl use and had the lowest levels of NPB use (2.2 % of days) at baseline. Class 3 (3 %) was characterized as the primary NPPO use group. Class 4 (5 %) transitioned from high levels of NPB use to increased MOUD treatment utilization. It had the highest levels of NPB use at baseline (average of 80.7 % of days) that decreased to an average of 12.9 % of days at 24 months. Class 5 (16 %) showed transition from high levels of heroin/fentanyl use to increased MOUD treatment utilization. Class 6 (27 %) showed decreased heroin/fentanyl use over time and low MOUD treatment utilization. Classes showed varying levels of improvement in psychosocial functioning, polydrug use, and overdose risks., Conclusion: Overall, our findings suggest that NPB use was generally self-limiting with individuals reducing their use over time as some engage in greater utilization of MOUD treatment. A need exists for continuing improvements in MOUD treatment access and retention., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Provision of opioid agonist treatment (OAT) in custodial settings is resource-intensive and may be associated with diversion, non-medical use, and violence. A clinical trial of a new OAT, depot buprenorphine (the UNLOC-T study), provided the opportunity to obtain health and correctional staff perspectives regarding this treatment prior to widespread roll-out., Methods: Sixteen focus groups with 52 participants were conducted, including 44 health staff (nurses, nurse practitioners, doctors, and operational staff) and eight correctional staff., Results: Key challenges to providing OAT identified as potentially being addressed by depot buprenorphine included 1) patient access, 2) OAT program capacity, 3) treatment administration procedures, 4) medication diversion and other safety issues and, 5) impact on other service delivery., Conclusions: The introduction of depot buprenorphine into correctional settings was considered to have the potential to increase safety for patients, improve staff / patient relations and advance patient health outcomes via expanded treatment coverage and efficiencies gained through enhanced health service delivery. Support was almost universal from both correctional and health staff participating in this study. These findings build on emerging research regarding the positive impact of more flexible OAT programs and could be used to engage support for the implementation of depot buprenorphine from staff in other secure settings., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: This project was funded by NSW Ministry of Health. Camurus AB provided Buvidal (CAM2038) with no right of veto of publication or dissemination of results. Adrian Dunlop, has received funding to their institution from Braeburn Pharmaceuticals (North American partners of Camurus AB) to support a previous community trial of Buvidal. No funds were provided directly to this individual and none of the investigators or their families hold shares in Camurus or Braeburn pharmaceuticals or stands to make financial gains through their involvement with Camurus AB., (Copyright © 2023. Published by Elsevier B.V.)

Background: Craving is a distressing symptom of opioid use disorder (OUD) that can be alleviated with medications for OUD (MOUD). Buprenorphine is an effective MOUD that may suppress craving; however, treatment discontinuation and resumed opioid use is common during the early phases of treatment. More information on the craving response through the high-risk period of initiating buprenorphine may provide meaningful information on how to better target craving, which in turn may enhance outcomes. This systematic review investigated buprenorphine doses and formulations on craving during the induction and maintenance phases of treatment, and for context also compared the craving response to other MOUD (i.e., methadone, extended-release naltrexone [XR-NTX])., Methods: PubMed, PsycInfo, Embase, and Cochrane Central databases were searched for randomized trials of buprenorphine versus placebo, various buprenorphine formulations/doses, or other MOUD that included a measure of opioid craving., Results: A total of 10 studies were selected for inclusion. Buprenorphine and buprenorphine/naloxone (BUP/NAL) were each associated with lower craving than placebo over time. Craving was greater among those prescribed lower versus higher buprenorphine doses. In comparison to other MOUD, buprenorphine or BUP/NAL was linked to greater craving than methadone in 3 of the 6 studies. BUP/NAL was associated with greater reported craving than XR-NTX., Discussion: Craving is reduced over time with buprenorphine and BUP/NAL, although other MOUD may provide greater reductions in craving. Although there is currently considerable variability in the measurement of craving, it may be a valuable concept to address with individuals receiving MOUD, especially early in treatment., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Introduction: Current WHO guidelines recommend using methadone or buprenorphine as maintenance treatments for maternal opioid use disorder. However, buprenorphine-naloxone, with a lower abuse risk than buprenorphine monotherapy or methadone, offers a potentially beneficial alternative, but scientific evidence on its effects on pregnancies, fetuses, and newborns is scarce. This paper compares the outcomes of the pregnancies, deliveries, and newborns of women on buprenorphine-naloxone, buprenorphine, or methadone maintenance treatments. According to the hypothesis, as a maintenance treatment, buprenorphine-naloxone does not have more adverse effects than buprenorphine, whereas methadone is more complicated., Material and Methods: In this population-based study, 172 pregnant women on medical-assisted treatments were followed-up at Helsinki University Women's Hospital (Finland). Women receiving the same opioid maintenance treatment from conception to delivery and their newborns were included. Consequently, 67 mother-child dyads met the final inclusion criteria. They were divided into three groups based on their opioid pharmacotherapy. The outcomes were compared among the groups and, where applicable, with the Finnish population., Results: The buprenorphine-naloxone and buprenorphine groups showed similar outcomes and did not significantly differ from each other in terms of maternal health during pregnancies, deliveries, or newborns. Illicit drug use during the pregnancy was common in all groups, but in the methadone group it was most common (p = 0.001). Most neonates (96%) were born full-term with good Apgar scores. They were of relatively small birth size, with those in the methadone group tending to be the smallest. Of the neonates 63% needed pharmacological treatment for neonatal opioid withdrawal syndrome. The need was lower in the buprenorphine-based groups than in the methadone group (p = 0.029)., Conclusions: Buprenorphine-naloxone seems to be as safe for pharmacotherapy for maternal opioid use disorder as buprenorphine monotherapy for both mother and newborn. Hence it could be a choice for oral opioid maintenance treatment during pregnancy, but larger studies are needed before changing the official recommendations. Women on methadone treatment carry multifactorial risks and require particularly cautious follow up. Furthermore, illicit drug use is common in all treatment groups and needs to be considered for all patients with opioid use disorder., (© 2022 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment., Methods: A multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms., Conclusion: This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD., Trial Registration: ClinicalTrials.gov Identifier: NCT04648228., Competing Interests: Declaration of Competing Interest These are required for all submissions. Declarations of interest do not indicate wrongdoing, but they must be declared in the interests of full transparency. Authors should declare sources of funding, direct or indirect, and any connection of any of the researchers with the tobacco, alcohol, cannabis, pharmaceutical or gaming industries or any body substantially funded by one of these organizations. Authors are also required to declare any financial conflict of interest arising from involvement with organizations that seek to provide help with or promote recovery from addiction. Any contractual constraints on publishing imposed by the funder must also be disclosed. Declaring a conflict of interest is the responsibility of authors and authors should err on the side of inclusiveness In line with the ICMJE conflict of interest policy, the time window for these financial links is within 3 years of the date of article submission. If an undeclared conflict of interest comes to light, we reserve the right to publish this prominently and to place it on a public register using words along the lines of ‘[name] has the following conflict of interest which h/she has not declared’., (Crown Copyright © 2023. Published by Elsevier Inc. All rights reserved.)

Background: The majority of patients with opioid use disorder do not receive medications for opioid use disorder (MOUD), especially in rural areas. The patient-centered access to healthcare framework posits access as a multidimensional phenomenon impacted by five healthcare system and five patient ability dimensions. Interventions to improve local MOUD treatment outcomes require an understanding of how these dimensions differ across urban and rural communities. This scoping review sought to systematically appraise the literature on MOUD access across urban and rural communities (i.e., rurality) in the US using the patient-centered access framework., Methods: We performed a scoping review of 1) electronic databases, 2) grey literature, and 3) correspondence with content experts (March 2021). We included articles specifying the study sample by rurality and examining at least one dimension of access to MOUD. The analysis and qualitative synthesis of study results examined study characteristics and categorized key findings by access dimensions., Results: The search produced 3963 unique articles, of which 147 met inclusion criteria. Among included studies, 96% (142/147) examined healthcare system dimensions of access while less than 20% (25/147) examined any of the five dimensions of patient ability. Additionally, 49% (72/147) of studies compared access dimensions by rurality. Across studies, increasing rurality was associated with fewer available MOUD services, but little was known about geographic variation in other critical dimensions of access., Conclusions: The vast majority of studies examined healthcare system dimensions of MOUD access and few studies made comparisons by rurality or prioritized the patient's perspective, limiting our understanding of how access differs by rurality in the US. As COVID-19 spurs novel changes in MOUD delivery, this inadequate multidimensional understanding of MOUD access may impede the tailoring of interventions to local needs. There is an urgent need for mixed-methods and community-engaged research prioritizing the patient's perspective of MOUD access by rurality., Registration: Open Science Framework (https://osf.io/wk6b9/)., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Aims: Sustained-release systems reduce the incidence of drug side effects and the need for frequent drug consumption, thus increasing patient compliance with treatment. In this study, we aimed to produce sustained-release buprenorphine (BP) using lipid-liquid crystal gels., Main Methods: The three experimental groups in this study included: group I: lipid-liquid crystal formulation 5 (F5) containing BP, group II: BP-free F5, group III: BP solution in NMP, and group IV: control (no treatment). The formulations were injected subcutaneously into the rabbits' back neck., Key Findings: The results showed that the time required to reach the drug's maximum concentration (T max ) was longer in group I than in group III. The maximum BP concentration (C max ) and the constants of the drug removal rate and drug absorption rate (K a ) were significantly higher in group III compared to group I. The half-life (t 1/2 ) of the drug in blood circulation was significantly longer in group I than in group III. Histopathological analysis revealed no histological abnormalities in the skin and heart in group I (BP-containing F5); however, mild hyperemia was observed in interstitial vessels in group III (BP-containing NMP). The kidney and liver tissues showed normal structure in the control group, as well as groups I and II. However, in the group receiving BP-containing NMP, significant congestion, tissue damage, necrosis, and fibrosis were observed in the kidney and liver., Significance: The results showed that the lipid-liquid crystal system can be used to design slow-release platforms for BP, minimizing the side effects associated with the use of its conventional forms., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

This paper is looking at the development of the Benzodiazepine and Opiate Withdrawal Service (BOWS) in the borough in Inner London to implement a model that would treat patients effectively in GP practices. It is to illustrate what can be achieved with experienced nurse prescribers in treating an emerging group of patients in primary care. Often patients are aware of their dependency on opiate medications and do want to reduce and come off their medications. This paper describes the BOWS service and its approach, illustrating what can be possible, in terms of treatment for patients in general practice. It also shows what can be designed in NHS services to address the growing issue of dependency on prescribed drugs and argues that services having experience in addictive behaviours can play a very large role in achieving this. [ABSTRACT FROM AUTHOR]

Medications for opioid use disorder (MOUD) increase retention in care and decrease mortality during active treatment; however, information about the comparative effectiveness of different forms of MOUD is sparse. Observational comparative effectiveness studies are subject to many types of bias; a robust framework to minimize bias would improve the quality of comparative effectiveness evidence. This paper discusses the use of target trial emulation as a framework to conduct comparative effectiveness studies of MOUD with administrative data. Using examples from our planned research project comparing buprenorphine‐naloxone and extended‐release naltrexone with respect to the rates of MOUD discontinuation, we provide a primer on the challenges and approaches to employing target trial emulation in the study of MOUD. [ABSTRACT FROM AUTHOR]

Opioid agonist therapy is first line in the management of opioid use disorder (OUD). Many guidelines support buprenorphine as the optimal treatment due to its preferred safety profile. Extended-release buprenorphine (BUP-XR) is a weekly or monthly subcutaneously administered formulation of buprenorphine. Emerging research has explored the use of BUP-XR in a variety of patient populations to guide clinicians in determining which patients may or may not benefit from BUP-XR. We conducted a literature review in Medline, PsycInfo and Embase to capture the literature to date on BUP-XR. Abstracts were reviewed, and papers which guided selection of individuals who would or would not benefit from BUP-XR were included. Our search returned 359 articles, and 31 met inclusion criteria. Special populations who may benefit from BUP-XR include individuals experiencing homelessness, incarceration, and medical or psychiatric comorbidity, while caution should be used around pregnancy. Patient preference and patient-centered outcomes were recurring considerations to guide the selection of BUP-XR. Extended-release buprenorphine formulations represent a relatively new tool for managing OUD and may specifically benefit patients undergoing transitions in care. Further research on the comparative effectiveness of extended-release versus daily-dosing formulations and in other populations of interest is needed. [ABSTRACT FROM AUTHOR]

The opioid epidemic in the United States disproportionately affects Medicaid beneficiaries than other groups. This results in a significant financial burden on state Medicaid programs. In this analysis, we investigate the association of medication for opioid use disorder (MOUD) treatment initiation and linkage to ongoing care on overall healthcare costs of Medicaid Fee-for-Service patients. We conducted a retrospective study among adult patients diagnosed with opioid use disorder (OUD) and who had a clinical encounter at a safety-net institution in Denver Colorado in 2020. Three categories of MOUD status of patients were defined: 1) identified with OUD but did not receive MOUD; 2) initiated MOUD but not linked to ongoing treatment and 3) received MOUD and linked to ongoing treatment. Our outcome variable was per-member per-month total healthcare cost. We estimated a multivariable model to test the association between healthcare cost and MOUD status, while controlling for demographic and risk classification variables. We found that in individuals with OUD who initiated MOUD treatment but were not linked to ongoing care had the highest healthcare cost, while those who were linked to ongoing MOUD treatment had the lowest healthcare cost. MOUD treatment is not only effective at addressing the significant morbidity and mortality burden of OUD but also associated with decreased financial cost, which is disproportionately incurred by Medicaid. Additional policy and care delivery changes are needed to focus efforts to improve linkage to ongoing treatment., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Opioid-related deaths continue to rise in the U.S. A shared decision-making (SDM) system to help primary care clinicians (PCCs) identify and treat patients with opioid use disorder (OUD) could help address this crisis., Methods: In this cluster-randomized trial, primary care clinics in three healthcare systems were randomized to receive or not receive access to an OUD-SDM system. The OUD-SDM system alerts PCCs and patients to elevated risk of OUD and supports OUD screening and treatment. It includes guidance on OUD screening and diagnosis, treatment selection, starting and maintaining patients on buprenorphine for waivered clinicians, and screening for common comorbid conditions. The primary study outcome is, of patients at high risk for OUD, the percentage receiving an OUD diagnosis within 30 days of index visit. Additional outcomes are, of patients at high risk for or with a diagnosis of OUD, (a) the percentage receiving a naloxone prescription, or (b) the percentage receiving a medication for OUD (MOUD) prescription or referral to specialty care within 30 days of an index visit, and (c) total days covered by a MOUD prescription within 90 days of an index visit., Results: The intervention started in April 2021 and continues through December 2023. PCCs and patients in 90 clinics are included; study results are expected in 2024., Conclusion: This protocol paper describes the design of a multi-site trial to help PCCs recognize and treat OUD. If effective, this OUD-SDM intervention could improve screening of at-risk patients and rates of OUD treatment for people with OUD., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: People released from jail are at elevated opioid overdose risk. Medications for opioid use disorder (MOUD) are effective in reducing overdoses. MOUD treatment was recently mandated in seven Massachusetts jails, but little is known about barriers and facilitators to treatment continuity post-release. We aimed to assess MOUD provider perspectives on treatment continuity among people released from jail., Methods: We conducted qualitative interviews with 36 medical, supervisory, and administrative staff at MOUD programs that serve jail-referred patients. We used the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation science framework to guide development of instruments, codes, and analyses. We employed deductive and inductive coding, and a grounded theory analytical approach to identify salient themes., Results: Inner context findings highlighted necessary adjustments among jail staff to approve MOUD treatment, especially with agonist medications that were previously considered contraband. Participants perceived that some staff within jails favored abstinence-based recovery, viewing agonists as a crutch. Bridging results highlighted the importance of inter-agency communication and coordination to ensure information transfer for seamless treatment continuity in the community post-release. Pre-release planning, release on pre-scheduled dates, medication provision to cover gaps between jail release and intake at community MOUD sites, and exchange of treatment information across agencies were viewed as paramount to success. Unexpected early releases and releases from court were viewed as barriers to treatment coordination. Outer context domains were largely tied to social determinants of health. Substantial barriers to treatment continuity included shelter, food security, employment, transportation, and insurance reactivation., Conclusion: Through qualitative interviews with community-based MOUD staff, we identified salient barriers and facilitators to treatment continuity post-release from jails. Findings point to needed investments in care coordination, staffing, and funding to strengthen jail-to-community-based MOUD treatment, removing barriers to continuity, and decreasing opioid overdose deaths during this high-risk transition., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)

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., (© 2022. The Author(s).)

Introduction: Opioid use disorder (OUD) and injection drug use (IDU) place justice-involved individuals at increased risk for acquiring or transmitting HIV or hepatitis C virus (HCV). Methadone and buprenorphine have been associated with reduced opioid IDU; however, the effect of extended-release naltrexone (XR-NTX) on this behavior is incompletely studied., Methods: This study examined injection opioid use and shared injection equipment behavior from a completed double-blind placebo-controlled trial of XR-NTX among 88 justice-involved participants with HIV and OUD. Changes in participants' self-reported daily injection opioid use and shared injection equipment was evaluated pre-incarceration, during incarceration, and monthly post-release for 6 months. The study also assessed differences in time to first opioid injection post-release. The research team performed intention to treat and "as treated" (high treatment versus low treatment) analyses., Results: Fifty-eight of 88 participants (69.5 %) endorsed IDU and 26 (29.5 %) reported sharing injection equipment in the 30 days pre-incarceration; 2 participants (2.2 %) reported IDU during incarceration; 19 (21.6 %) reported IDU one month post-release from prison or jail. Fifty-four (61.4 %) participants had an HIV RNA below 200 copies/mL and 62 (70.5 %) were baseline HCV antibody positive. The 6-month follow-up rate was 49.5 % and 50.5 % for those who received XR-NTX and placebo, respectively, which was not significantly different (p = 0.822). Participants in the XR-NTX and placebo groups had similar low mean opioid injection use post-release and time to first injection opioid use in the Intention-to-treat analysis. In the as-treated analysis, participants in the high treatment group had significantly lower mean proportion of days injecting opioids (13.8 % high treatment versus 22.8 % low treatment, p = 0.02) by month 1, which persisted up to 5 months post-release (0 % high treatment vs 24.3 % low treatment, p < 0.001) and experienced a longer time to first opioid injection post-release (143.8 days high treatment vs 67.4 days low treatment, p < 0.001)., Conclusions: Injection opioid use was low during incarceration and remained low post-release in this justice-involved population. Retention on XR-NTX was associated with reduced intravenous opioid use, which has important implications for reducing transmission of HIV and HCV., Competing Interests: Declaration of competing interest Author SAS has provided scientific consultation to Alkermes Inc. and received NIH and VA grant funding. SAS has received in-kind study drug donations from Alkermes Inc. and Indivior Pharmaceutical Company for NIH-funded research. The authors alone are responsible for the content and writing of this paper., (Published by Elsevier Inc.)

Background: Individuals with opioid use disorder released to communities after incarceration experience an elevated risk for overdose death. Massachusetts is the first state to mandate county jails to deliver all FDA approved medications for opioid use disorder (MOUD). The present study considered perspectives around coordination of post-release care among jail staff engaged in MOUD programs focused on coordination of care to the community., Methods: Focus groups and semi-structured interviews were conducted with 61 jail staff involved in implementation of MOUD programs. Interview guide development, and coding and analysis of qualitative data were guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Deductive and inductive approaches were used for coding and themes were organized using the EPIS., Results: Salient themes in the inner context focused on the elements of reentry planning that influence coordination of post-release care including timing of initiation, staff knowledge about availability of MOUD in community settings, and internal collaborations. Findings on bridging factors highlighted the importance of interagency communication to follow pre-scheduled release dates and use of bridge scripts to minimize the gap in treatment during the transition. Use of navigators was an additional factor that influenced MOUD initiation and engagement in community settings. Outer context findings indicated partnerships with community providers and timely reinstatement of health insurance coverage as critical factors that influence coordination of post-release care., Conclusions: Coordination of MOUD post-release continuity of care requires training supporting staff in reentry planning as well as resources to enhance internal collaborations and bridging partnerships between in-jail MOUD programs and community MOUD providers. In addition, efforts to reduce systemic barriers related to unanticipated timing of release and reinstatement of health insurance coverage are needed to optimize seamless post-release care., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)

Background: The use of opioids is increasing globally, but data from low- and middle-income countries on opioid-related mental and behavioural disorders (hereafter referred to as opioid-related disorders) are scarce. This study examines the incidence of opioid-related disorders, opioid agonist use, and excess mortality among persons with opioid-related disorders in South Africa's private healthcare sector., Methods: We analysed longitudinal data of beneficiaries (≥ 11 years) of a South African medical insurance scheme using reimbursement claims from Jan 1, 2011, to Jul 1, 2020. Beneficiaries were classified as having an opioid-related disorder if they received an opioid agonist (buprenorphine or methadone) or an ICD-10 diagnosis for harmful opioid use (F11.1), opioid dependence or withdrawal (F11.2-4), or an unspecified or other opioid-related disorder (F11.0, F11.5-9). We calculated adjusted hazard ratios (aHR) for factors associated with opioid-related disorders, estimated the cumulative incidence of opioid agonist use after receiving an ICD-10 diagnosis for opioid dependence or withdrawal, and examined excess mortality among beneficiaries with opioid-related disorders., Results: Of 1,251,458 beneficiaries, 1286 (0.1%) had opioid-related disorders. Between 2011 and 2020, the incidence of opioid-related disorders increased by 12% (95% CI 9%-15%) per year. Men, young adults in their twenties, and beneficiaries with co-morbid mental health or other substance use disorders were at increased risk of opioid-related disorders. The cumulative incidence of opioid agonist use among beneficiaries who received an ICD-10 diagnosis for opioid dependence or withdrawal was 18.0% (95% CI 14.0-22.4) 3 years after diagnosis. After adjusting for age, sex, year, medical insurance coverage, and population group, opioid-related disorders were associated with an increased risk of mortality (aHR 2.28, 95% CI 1.84-2.82). Opioid-related disorders were associated with a 7.8-year shorter life expectancy., Conclusions: The incidence of people diagnosed with or treated for an opioid-related disorder in the private sector is increasing rapidly. People with opioid-related disorders are a vulnerable population with substantial psychiatric comorbidity who often die prematurely. Evidence-based management of opioid-related disorders is urgently needed to improve the health outcomes of people with opioid-related disorders., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper, (Copyright © 2022. Published by Elsevier B.V.)