Alkyl Substituent in Heterocyclic Substrate, Carbon Skeleton Length of O-Nucleophilic Agent and Conditions Influence the Product Composition from Competitive Reactions of SNipso Substitution by Aliphatic Oligoethers.

Using 1H NMR spectroscopy, we studied the relative mobility of the NO2 group in 1-alkyl-5-nitro-1,2,4-triazoles in the reaction of nucleophilic heterocyclic substitution by aliphatic oligoethers. The main pathways of the SNipso substitution process and the composition of resultant products from competitive reactions were examined, and the key factors influencing the relative mobility of the nitro group, such as the nitrotriazole substrate constitution, the carbon skeleton length of the O-nucleophilic agent and the process conditions, were discussed. Several independent competitive reactions directed towards the substitution of the nitro group at position C(5) in the alkyltriazole substrate by different types of nucleophiles such as alkoxide-, hydroxide- and triazolonate anions were observed to take place under conditions used. The major reaction yielded oligoethers containing terminal alkyltriazole heterocycles. Secondary reactions occurred to form the corresponding triazolone and N-C triazolyl triazolone structures in the reaction system. Additionally, in excess of the alkaline agent, alkaline hydrolysis was observed to proceed at the final stages of the process involving the O-nucleophile having a longer oligoether backbone in the series studied, leading to the formation of new O-nucleophilic sites. The obtained findings can provide a foundation for devising a method for the modification of a wide range of commercially available aliphatic oligo- or polyethers to prepare functional macromolecules whose terminals carry bioactive 1,2,4-triazole heterocycles located at a desired distance from each other.

Diversion of medications to treat opioid use disorder: Qualitative findings from formerly incarcerated adults in Massachusetts.

BACKGROUND: Carceral officials often cite diversion of medication for opioid use disorder (MOUD) (e.g., buprenorphine) as a reason for not offering MOUD treatment in jails and prisons with little understanding of patient perspectives. We aimed to understand patient perceptions of medication diversion from jail-based MOUD programs and the factors that contribute to and reduce diversion. METHODS: We conducted thematic analyses of semi-structured interviews held in 2021-22 with 38 adults who received MOUD treatment and were released from eight Massachusetts jails that had implemented a MOUD program on or after September 2019. RESULTS: Consistent with prior reports from carceral staff, patients perceived MOUD diversion to happen less frequently than expected, which they attributed to dosing protocols that have effectively reduced it. Patients reported that MOUD availability reduced the contraband buprenorphine market, although other contraband substances have entered jails (fentanyl, oxycodone, K2). Patients perceived Subutex to have greater misuse potential and added diversion risks. Patients valued graduated consequences and other efforts to reduce MOUD diversion and contraband for making jails safer and for enabling patients to receive treatment. Nearly all participants reported having heard about, witnessed, or been involved in actual or attempted diversion, with variation in reports by jail. Patients suggested that dispensing MOUD to all who need it immediately upon intake would be the most effective way to reduce MOUD diversion and contraband. CONCLUSION: Formerly incarcerated patients perceived MOUD diversion within jail medication programs as occurring less often than expected and that it can be reduced with appropriate protocols. To help limit medication diversion, patients recommended provision of MOUD upon intake to all individuals with opioid use disorder who need it. Findings have implications for MOUD program adaptation, successful routinization, and diffusion in carceral settings.

COVID-19 impact on opioid overdose after jail release in Massachusetts.

Introduction: Release from incarceration is a high-risk period for opioid overdose. Concern about COVID-19 spread in jails led to early releases; it is unknown whether pandemic era releases of persons with opioid use disorder (OUD) contributed to increases in community overdose rates. Methods: Observational data compared overdose rates three months after release among jailed persons with OUD released before (9/1/2019-3/9/2020) and during the pandemic (3/10/2020-8/10/2020) from seven jails in Massachusetts. Data on overdoses come from the Massachusetts Ambulance Trip Record Information System and Registry of Vital Records Death Certificate file. Other information came from jail administrative data. Logistic models regressed overdose on release period, controlling for MOUD received, county of release, race/ethnicity, sex, age, and prior overdose. Results: Pandemic releases with OUD had a higher risk of fatal overdose (adjusted odds ratio [aOR] 3.06; 95% CI, 1.49 to 6.26); 20 persons released with OUD (1.3%) experienced a fatal overdose within three months of release, versus 14 (0.5%) pre-pandemic. MOUD had no detectable relationship with overdose mortality. Pandemic release did not impact non-fatal overdose rates (aOR 0.84; 95% CI 0.60 to 1.18), though in-jail methadone treatment was protective (aOR 0.34; 95% CI 0.18 to 0.67). Conclusions: Persons with OUD released from jail during the pandemic experienced higher overdose mortality compared to pre-pandemic, but the number of deaths was small. They did not experience significantly different rates of non-fatal overdose. Early jail releases during the pandemic were unlikely to explain much, if any, of the observed increase in community overdoses in Massachusetts.

Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers.

INTRODUCTION: Access to medications for opioid use disorder (MOUD) is limited for individuals in drug courts - programs that leverage sanctions for mandatory substance use treatment. Drug courts rely on community agencies to provide MOUD. However, relationships with MOUD agencies, which impact access to treatment, are understudied. We examined barriers and facilitators from drug court staffs' perspectives to understand how to enhance collaborations with MOUD providers. METHODS: Drug court staff (n = 21) from seven courts participated in semi-structured interviews about their experience in collaborating with MOUD providers. Interviews were informed by the Consolidated Framework for Implementation Research. Inductive (theory-based) and deductive (ground-up) approaches were used for analyses. RESULTS: Facilitator and barrier themes centered around the needs and resources of drug court participants, external policies such MOUD access in jails, networking with external agencies, and beliefs about MOUD providers. Drug court staff preferred working with agencies that offered MOUD alongside comprehensive services. Drug courts benefited when jails offered MOUD in-house and facilitated community referrals. Existing relationships with providers and responsive communication eased referrals and served to educate the courts about MOUD. Barriers included logistical limitations (limited hours, few methadone providers) and inadequate communication patterns between providers and drug court staff. A lack of confidence in providers' prescribing practices and concerns around perceived overmedication of participants impacted referrals, interagency collaboration, and further burdened the participants. CONCLUSIONS: Collaboration between drug courts and MOUD providers was driven by patient needs, external policies, communication patterns, and perceptions. Interventions to increase access MOUD for drug court participants will need to incorporate collaboration strategies while considering the unique features of drug courts.

Anticancer and antimicrobial activity of new copper (II) complexes.

In this study, three new organic ligands N'-(benzylidene)-6-chloropyrazine-2-carbohydrazonamide (L1), 6-chloro-N'-(4-nitrobenzylidene)picolinohydrazonamide(L2), and N'-(benzylidene)-4-chloropicolinohydrazonamide (L3) and three copper coordination compounds (Cu(L1)Cl2, Cu(L2)Cl2 and Cu(L3)Cl2) based on them were synthesized. All obtained compounds were characterized using appropriate analytical techniques: elemental analysis (EA), thermogravimetric analysis (TG-DTG), Fourier transform infrared spectroscopy (FTIR) and flame-atomic absorption spectrometry (F-AAS). These methods of physicochemical analyses helped to assume that the complexation in three cases proceeds in a bidentate manner. The X-ray investigation confirmed the synthesis pathway and molecular structures for L1 and L3 ligands. The antimicrobial activity of the obtained compounds was then comprehensively investigated, where Cu(L3)Cl2 showed the strongest antibacterial properties against all tested bacteria (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli). LN229 human glioma cells and BJ human normal fibroblasts cells were treated with tested compounds and their cytotoxicity was evaluated with MTT test. The effect of complexing on antitumor activity has been investigated. The ligand L1 and its complex showed similar activity against normal cells while complexation increases toxicity against cancer cells in concentrations of 50 and 100 µM. For the one pair of ligand/complex compounds the apoptosis detection, cell cycle analysis and gene expression analysis (qRT-PCR) were performed. Cu(L1)Cl2 showed the stronger toxic effect in comparison with L1 due to the population of early apoptotic cells which revealed metabolic activity in MTT assay.

New 5-Aminotetrazole-Based Energetic Polymers: Synthesis, Structure and Properties.

An N-glycidyl-5-aminotetrazole homopolymer was synthesized herein by nucleophilic substitution of 5-aminotetrazole heterocycles for chlorine atoms in poly-(epichlorohydrin)-butanediol. Copolymers of N-glycidyl-5-aminotetrazole and glycidyl azide with a varied ratio of energetic elements were synthesized by simultaneously reacting the 5-aminotetrazole sodium salt and the azide ion with the starting polymeric matrix. The 5-aminotetrazole-based homopolymer was nitrated to furnish a polymer whose macromolecule is enriched additionally with energy-rich terminal ONO2 groups and nitrate anions. The structures of the synthesized polymers were characterized by 1H and 13C NMR and IR spectroscopies, elemental analysis and gel-permeation chromatography. The densities were experimentally measured, and thermal stability data were acquired by differential scanning calorimetry. The insertion of aminotetrazole heterocycles into the polymeric chain and their modification via nitration provides an acceptable thermal stability and a considerable enhancement in density and nitrogen content compared to azide homopolymer GAP. By the 1.3-dipolar cycloaddition reaction, we demonstrated the conceptual possibility of preparing spatially branched, energy-rich polymeric binders bearing 5-aminotetrazole and 1,2,3-triazole heterocycles starting from the plasticized azide copolymers. The presence of the aforesaid advantages makes the reported polymers attractive candidates for use as a scaffold of energetic binders.

Synthesis and Biological Evaluation of Thiazole-Based Derivatives with Potential against Breast Cancer and Antimicrobial Agents.

Investigating novel, biologically-active coordination compounds that may be useful in the design of breast anticancer, antifungal, and antimicrobial agents is still the main challenge for chemists. In order to get closer to solving this problem, three new copper coordination compounds containing thiazole-based derivatives were synthesized. The structures of the synthesized compounds and their physicochemical characterization were evaluated based on elemental analysis, 1H and l3C nuclear magnetic resonance (NMR), flame atomic absorption spectroscopy (F-AAS), single-crystal X-ray diffraction, thermogravimetric analysis (TGA), and Fourier-transform infrared spectroscopy (FTIR). The pharmacokinetics were studied using SwissADME. The results obtained from the computational studies supported the results obtained from the MTT analysis, and the antimicrobial activity was expressed as the minimum inhibitory concentration (MIC).

Medication for opioid use disorder treatment continuity post-release from jail: A qualitative study with community-based treatment providers.

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.

Jail-based reentry programming to support continued treatment with medications for opioid use disorder: Qualitative perspectives and experiences among jail staff in Massachusetts.

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.

New Coordination Compounds Based on a Pyrazine Derivative: Design, Characterization, and Biological Study.

New coordination compounds of Mn(II), Fe(III), Co(II), and Ni(II) and the biologically active ligand L (N'-benzylidenepyrazine-2-carbohydrazonamide) were synthesized and characterized by appropriate analytical techniques: elemental analysis (EA), thermogravimetric analysis (TG-DTG), infrared spectroscopy (FTIR), and flame-atomic absorption spectrometry (F-AAS). The biological activity of the obtained compounds was then comprehensively investigated. Rational use of these compounds as potential drugs was proven by ADME analysis. All obtained compounds were screened in vitro for antibacterial, antifungal, and anticancer activities. Some of the studied complexes exhibited significantly higher activity than the ligand alone.

Antitumor Activity and Physicochemical Properties of New Thiosemicarbazide Derivative and Its Co(II), Ni(II), Cu(II), Zn(II) and Cd(II) Complexes.

A novel biologically active thiosemicarbazide derivative ligand L (N-[(phenylcarbamothioyl)amino]pyridine-3-carboxamide) and a series of its five metal(II) complexes, namely: [Co(L)Cl2], [Ni(L)Cl2(H2O)], [Cu(L)Cl2(H2O)], [Zn(L)Cl2] and [Cd(L)Cl2(H2O)] have been synthesized and thoroughly investigated. The physicochemical characterization of the newly obtained compounds has been performed using appropriate analytical techniques, such as 1H and l3C nuclear magnetic resonance (NMR), inductively coupled plasma (ICP), thermogravimetric analysis (TGA), Fourier-transform infrared spectroscopy (FTIR) and magnetic measurements. In order to study the pharmacokinetic profile of the compounds, ADMET analysis was performed. The in vitro studies revealed that the synthesized compounds exhibit potent biological activity against A549 human cancer cell line.

Uncommon and preventable: Perceptions of diversion of medication for opioid use disorder in jail.

INTRODUCTION: Correctional officials often cite diversion of medication for opioid use disorder (MOUD) treatment (e.g., buprenorphine) as a reason for not offering MOUD treatment in jails and prisons, but it is poorly understood whether these fears are justified. We aimed to understand staff perceptions of medication diversion from jail-based MOUD programs and the factors that contribute to and prevent diversion. METHODS: We conducted qualitative analyses of semi-structured in-depth interviews and focus groups performed in 2019-20 with 61 administrative, security, behavioral health, and clinical staff who implement MOUD programming in seven Massachusetts jails. RESULTS: Contrary to staff expectations, buprenorphine diversion was perceived to occur infrequently during MOUD program implementation. The MOUD program changed staff views of buprenorphine, i.e., as legitimate treatment instead of as illicit contraband. Also, the program was perceived to have disrupted the illicit buprenorphine market in jail and reduced related coercion. Proactive strategies were essential to prevent and respond to buprenorphine diversion. Key components of diversion prevention strategies included: staff who distinguished among different reasons for diversion; comprehensive and routinized but flexible dosing protocols; communication, education, and monitoring; patient involvement in assessing reasons for diversion; and written policies to adjudicate diversion consequences. CONCLUSION: With appropriate protocols, buprenorphine diversion within correctional programs designed to provide MOUD treatment is perceived to be uncommon and preventable. Promising practices in program design help limit medication diversion and inform correctional officials and lawmakers as they consider whether and how to provide MOUD treatment in correctional settings.

Legislatively mandated implementation of medications for opioid use disorders in jails: A qualitative study of clinical, correctional, and jail administrator perspectives.

BACKGROUND: Individuals with legal involvement and opioid use disorders (OUD) are at an increased risk of overdose and premature death. Yet, few correctional systems provide all FDA approved medications for OUD (MOUD) to all qualifying incarcerated individuals. We report on the implementation of MOUD in seven Massachusetts' jails following a state legislative mandate to provide access to all FDA-approved MOUD and to connect with treatment upon release. METHODS/PARTICIPANTS: Based on the Exploration, Preparation, Implementation, and Sustainment framework, 61 clinical, corrections, and senior jail administrators participated in semi-structured interviews and focus groups between December 2019 and January 2020. Qualitative analyses focused on external and internal contexts and bridging factors. FINDINGS: Participants detailed how the outer context (i.e., legislative mandate) drove acceptance of MOUD and assisted with continuity of care. Salient inner context factors included decision-making around administration of agonist medications, staff perceptions and training, and changes to infrastructure and daily routines. Leadership was critical in flattening standard hierarchies and advocating for flexibility. System-based characteristics of incarcerated individuals, specifically those who were pre-sentenced, presented challenges with treatment initiation. Inter- and intra-agency bridging factors reduced duplication of effort and led to quick, innovative solutions. CONCLUSIONS: Implementation of MOUD in jails requires collaboration with and reliance on external agencies. Preparation for implementation should involve systematic reviews of available resources and connections. Implementation requires flexibility from institutional systems that are inherently rigid. Accordingly, leaders and policymakers must recognize the cultural shift inherent in such programs and allow for resources and education to assure program success.

Energetic Materials Based on N-substituted 4(5)-nitro-1,2,3-triazoles.

The regularities and synthetic potentialities of the alkylation of 4(5)-nitro-1,2,3-triazole in basic media were explored, and new energetic ionic and nitrotriazole-based coordination compounds were synthesized in this study. The reaction had a general nature and ended with the formation of N1-, N2-, and N3-alkylation products, regardless of the conditions and reagent nature (alkyl- or aryl halides, alkyl nitrates, dialkyl sulfates). This reaction offers broad opportunities for expanding the variability of substituents on the nitrotriazole ring in the series of primary and secondary aliphatic, alicyclic, and aromatic substituents, which is undoubtedly crucial for solving the problems related to both high-energy materials development and medicinal chemistry when searching for new efficient bioactive compounds. An efficient methodology for the separation of regioisomeric N-alkyl(aryl)nitrotriazoles has been devised and relies on the difference in their basicity and reactivity during quaternization and complexation reactions. Based on the inaccessible N3-substitution products that exhibit a combination of properties of practical importance, a series of energy-rich ionic systems and coordination compounds were synthesized that are gaining ever-increasing interest for the chemistry of energy-efficient materials, coordination chemistry, and chemistry of ionic liquids.

Assessing feigning with the Feigning Evaluation INtegrating Sources (FEINS) in a forensic psychiatric sample.

Evaluators of examinees in forensic contexts must consider the potential for falsified or exaggerated psychiatric symptoms and/or cognitive deficits. A number of validated assessment tools assist evaluators in identifying those examinees who feign impairment; however, no comprehensive method has been established for consolidating data from multiple tests, interviews, behavioral observations, and collateral sources. The current pilot study preliminarily examined the interrater reliability and validity of a new forensic assessment tool, the Feigning Evaluation INtegrating Sources (FEINS), developed to guide evaluators in the comprehensive assessment of feigning by adding structure to the collection of relevant data. Fifty-eight male pretrial defendants undergoing restoration of competency to stand trial at a state forensic psychiatric center participated in the study. Results provided preliminary support for reliability in scoring the FEINS, construct validity, and predictive validity. FEINS items that assessed clinical presentation, and those that guided the use of test data, were more useful than items capturing historical/demographic data. Structured professional judgments developed using the FEINS appeared to be more accurate in predicting competency evaluators' perceptions of feigning than both unstructured clinical judgment (i.e., referring psychologist's perception of feigning) alone and test data alone, using hierarchical multiple regressions. Findings suggest that the FEINS may have practical utility in guiding clinical opinions regarding feigning across psychiatric, cognitive, and psycholegal/functional domains. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Experiences of Court Clinicians Who Perform Civil Commitment Evaluations for Substance Use Disorders.

Civil commitment for substance use disorders is an increasingly used intervention to mitigate the risks associated with severe substance use. Although court clinicians play a vital role in helping courts determine whether respondents meet statutory requirements for commitment, little is known about their experiences conducting these evaluations. In this pilot study, we surveyed all court clinicians who perform evaluations for civil commitment for substance use disorders in Massachusetts, a state with one of the highest rates of such commitments nationally. Court clinicians reported that these evaluations are most frequently ordered for individuals who use heroin and other opioids, alcohol, and cannabis. They reported a recent suicide attempt or drug overdose, intentional physical harm to another, use of dangerous weapon, and driving while intoxicated as the behaviors most likely to satisfy the statutory requirement of imminent risk. At the same time, many court clinicians consider a much broader range of behaviors as constituting imminent risk, and many reported having endorsed commitment on one or more occasions in the absence of statutory criteria being satisfied. These findings underscore the need for additional research on the performance of civil commitment evaluations for substance use disorder and standards for such evaluations.

Massachusetts Justice Community Opioid Innovation Network (MassJCOIN).

A major driver of the U.S. opioid crisis is limited access to effective medications for opioid use disorder (MOUD) that reduce overdose risks. Traditionally, jails and prisons in the U.S. have not initiated or maintained MOUD for incarcerated individuals with OUD prior to their return to the community, which places them at high risk for fatal overdose. A 2018 law (Chapter 208) made Massachusetts (MA) the first state to mandate that five county jails deliver all FDA-approved MOUDs (naltrexone [NTX], buprenorphine [BUP], and methadone). Chapter 208 established a 4-year pilot program to expand access to all FDA-approved forms of MOUD at five jails, with two more MA jails voluntarily joining this initiative. The law stipulates that MOUD be continued for individuals receiving it prior to detention and be initiated prior to release among sentenced individuals where appropriate. The jails must also facilitate continuation of MOUD in the community on release. The Massachusetts Justice Community Opioid Innovation Network (MassJCOIN) partnered with these seven diverse jails, the MA Department of Public Health, and community treatment providers to conduct a Type 1 hybrid effectiveness-implementation study of Chapter 208. We will: (1) Perform a longitudinal treatment outcome study among incarcerated individuals with OUD who receive NTX, BUP, methadone, or no MOUD in jail to examine postrelease MOUD initiation, engagement, and retention, as well as fatal and nonfatal opioid overdose and recidivism; (2) Conduct an implementation study to understand systemic and contextual factors that facilitate and impede delivery of MOUDs in jail and community care coordination, and strategies that optimize MOUD delivery in jail and for coordinating care with community partners; (3) Calculate the cost to the correctional system of implementing MOUD in jail, and conduct an economic evaluation from state policy-maker and societal perspectives to compare the value of MOUD prior to release from jail to no MOUD among matched controls. MassJCOIN made significant progress during its first six months until the COVID-19 pandemic began in March 2020. Participating jail sites restricted access for nonessential personnel, established other COVID-19 mitigation policies, and modified MOUD programming. MassJCOIN adapted research activities to this new reality in an effort to document and account for the impacts of COVID-19 in relation to each aim. The goal remains to produce findings with direct implications for policy and practice for OUD in criminal justice settings.

Impact of extended release naltrexone on health-related quality of life in individuals with legal involvement and opioid use disorders.

Background: Understanding the impact of medications for opioid use disorder on health related quality of life (QOL) may help to explain why few individuals with legal involvement remain in treatment, specifically those receiving opioid antagonists. QOL is an established predictor of treatment retention and has been shown to improve with some treatment for opioid use disorder. Yet limited research has examined QOL with opioid antagonists. We examined the impact of extended release naltrexone (XR-NTX) on QOL and retention in treatment in a randomized, multi-site trial of individuals with legal involvement. Methods: The participants were 308 community-dwelling adults with current or recent legal involvement with opioid dependence at five site across United States. They were randomized to receive XR-NTX or treatment as usual for 6 months. QOL was measured every 2 weeks using Euro QOL individual items, summary index score, and health state today metric. Results: No significant difference in QOL scores were observed between the two groups at the completion of active treatment or on follow up at 52 and 78 weeks. There were no time effects of treatment on scores. Contrary to expectation, baseline and average QOL did not predict retention in treatment. Conclusion: In contrast to prior research, our findings did not demonstrate significant changes (improvements or decreases) in QOL associated with XR-NTX treatment. Clinicians may consider that individuals receiving XR-NTX may not experience changes in perceived well-being in response to treatment and consider discussing with patients that they may not necessarily perceive improvement in their QOL. This may help to ground patient's expectations about the effects of treatment and potentially reduce attrition from treatment with opioid antagonists.

Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

When IRBs Say No to Participating in Research about Single IRBs.

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.