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The real unmet need: A multifactorial approach for identifying sensitized kidney candidates with low access to transplant
Maldonado, Angela Q; Bradbrook, Keighly; Sjöholm, Kristoffer; Kjellman, Christian; Lee, Joshua; Stewart, Darren
BACKGROUND:At the start of 2020, the kidney waiting list consisted of 2526 candidates with a calculated panel reactive antibody (CPRA) of 99.9% or greater, a cohort demonstrated in published research to have meaningfully lower than average access to transplantation even under the revised kidney allocation system (KAS). METHODS:This was a retrospective analysis of US kidney registrations using data from the OPTN [Reference (https://optn.transplant.hrsa.gov/data/about-data/)]. The period-prevalent study cohort consisted of US kidney-alone registrations who waited at least 1 day between April 1, 2016, when HLA DQ-Alpha and DP-Beta unacceptable antigen data became available in OPTN data collection, to December 31, 2019. Poisson rate regression was used to model deceased donor kidney transplant rates per active year waiting and using an offset term to account for differential at-risk periods. Median time to transplant was estimated for each IRR group using the Kaplan-Meier method. Sensitivity analyses were included to address geographic variation in supply-to-demand ratios and differences in dialysis time or waiting time. RESULTS:In this study, we found 1597 additional sensitized (CPRA 50-<99.9%) candidates with meaningfully lower than average access to transplant when simultaneously taking into account CPRA and other factors. In combination with CPRA, candidate blood type, Estimated Post-Transplant Survival Score (EPTS), and presence of other antibody specificities beyond those in the current, 5-locus CPRA were found to influence the likelihood of transplant. CONCLUSION:In total, this suggests approximately 4100 sensitized candidates are on the waiting list who represent a community of disadvantaged patients who may benefit from progressive therapies and interventions to facilitate incompatible transplantation. Though associated with higher risks, such interventions may nevertheless be more attractive than remaining on dialysis with the associated accumulation of mortality risk over time.
PMID: 36841966
ISSN: 1399-0012
CID: 5507792
Association between jail-based methadone or buprenorphine treatment for opioid use disorder and overdose mortality after release from New York City jails 2011-2017
Lim, Sungwoo; Cherian, Teena; Katyal, Monica; Goldfeld, Keith S; McDonald, Ryan; Wiewel, Ellen; Khan, Maria; Krawczyk, Noa; Braunstein, Sarah; Murphy, Sean M; Jalali, Ali; Jeng, Philip J; MacDonald, Ross; Lee, Joshua D
BACKGROUND AND AIMS/OBJECTIVE:Opioid overdose is a leading cause of death during the immediate time after release from jail or prison. Most jails in the United States do not provide methadone and buprenorphine treatment for opioid use disorder (MOUD), and research in estimating its impact in jail settings is limited. We aimed to test the hypothesis that in-jail MOUD is associated with lower overdose mortality risk post-release. DESIGN, SETTING AND PARTICIPANTS/METHODS:Retrospective, observational cohort study of 15 797 adults with opioid use disorder who were released from New York City jails to the community in 2011-17. They experienced 31 382 incarcerations and were followed up to 1 year. MEASUREMENTS/METHODS:The primary outcomes were death caused by accidental drug poisoning and all-cause death. The exposure was receipt of MOUD (17 119 events) versus out-of-treatment (14 263 events) during the last 3 days before community reentry. Covariates included demographic, clinical, behavioral, housing, healthcare utilization, and legal characteristics variables. We performed multivariable, mixed-effect Cox regression analysis to test association between in-jail MOUD and deaths. FINDINGS/RESULTS:A majority were male (82%) and their average age was 42 years. Receiving MOUD was associated with misdemeanor charges, being female, injection drug use, and homelessness. During 1 year post-release, 111 overdose deaths occurred, and crude death rates were 0.49 and 0.83 per 100 person-years for in-jail MOUD and out-of-treatment groups, respectively. Accounting for confounding and random effects, in-jail MOUD was associated with lower overdose mortality risk (adjusted hazard ratio = 0.20, 95% CI = 0.08-0.46), and all-cause mortality risk (adjusted hazard ratio = 0.22, 95% CI = 0.11-0.42) for the first month post-release. CONCLUSIONS:Methadone and buprenorphine treatment for opioid use disorder during incarceration was associated with an 80% reduction in overdose mortality risk for the first month post-release.
PMID: 36305669
ISSN: 1360-0443
CID: 5359662
The impact of COVID-19 on the treatment of opioid use disorder in carceral facilities: a cross-sectional study
Saunders, Elizabeth C; Satcher, Milan F; Monico, Laura B; McDonald, Ryan D; Springer, Sandra A; Farabee, David; Gryczynski, Jan; Nyaku, Amesika; Reeves, Donald; Kunkel, Lynn E; Schultheis, Alysse M; Schwartz, Robert P; Lee, Joshua D; Marsch, Lisa A; Waddell, Elizabeth Needham
While the COVID-19 pandemic disrupted healthcare delivery everywhere, persons with carceral system involvement and opioid use disorder (OUD) were disproportionately impacted and vulnerable to severe COVID-associated illness. Carceral settings and community treatment programs (CTPs) rapidly developed protocols to sustain healthcare delivery while reducing risk of COVID-19 transmission. This survey study assessed changes to OUD treatment, telemedicine use, and re-entry support services among carceral and CTPs participating in the National Institute on Drug Abuse (NIDA)-funded study, Long-Acting Buprenorphine vs. Naltrexone Opioid Treatments in Criminal Justice System-Involved Adults (EXIT-CJS) study. In December 2020, carceral sites (n = 6; median pre-COVID 2020 monthly census = 3468 people) and CTPs (n = 7; median pre-COVID 2020 monthly census = 550 patients) participating in EXIT-CJS completed a cross-sectional web-based survey. The survey assessed changes pre- (January-March 2020) and post- (April-September 2020) COVID-19 in OUD treatment, telemedicine use, re-entry supports and referral practices. Compared to January-March 2020, half of carceral sites (n = 3) increased the total number of persons initiating medication for opioid use disorder (MOUD) from April-September 2020, while a third (n = 2) decreased the number of persons initiated. Most CTPs (n = 4) reported a decrease in the number of new admissions from April-September 2020, with two programs stopping or pausing MOUD programs due to COVID-19. All carceral sites with pre-COVID telemedicine use (n = 5) increased or maintained telemedicine use, and all CTPs providing MOUD (n = 6) increased telemedicine use. While expansion of telemedicine services supported MOUD service delivery, the majority of sites experienced challenges providing community support post-release, including referrals to housing, employment, and transportation services. During the COVID-19 pandemic, this small sample of carceral and CTP sites innovated to continue delivery of treatment for OUD. Expansion of telemedicine services was critical to support MOUD service delivery. Despite these innovations, sites experienced challenges providing reintegration supports for persons in the community. Pre-COVID strategies for identifying and engaging individuals while incarcerated may be less effective since the pandemic. In addition to expanding research on the most effective telemedicine practices for carceral settings, research exploring strategies to expand housing and employment support during reintegration are critical.
PMCID:9760540
PMID: 36529829
ISSN: 2194-7899
CID: 5394902
Opioid Use Disorder Treatments: An Evidence Map
Sugarman, Allison; Vittitow, Alexandria; Cheng, Anna; Malone, Mia; McDonald, Ryan; Pace, Nancy; Williams, Ololade; Tofighi, Babak; McNeely, Jennifer; Schatz, Daniel; Roberts, Timothy; Hey, Spencer Phillips; Garrity, Kathleen; Lindquist, Kristin; Lee, Joshua D
BACKGROUND:Evidence maps are emerging data visualization of a systematic review. There are no published evidence maps summarizing opioid use disorder (OUD) interventions. AIM/OBJECTIVE:Our aim was to publish an interactive summary of all peer-reviewed interventional and observational trials assessing the treatment of OUD and common clinical outcomes. METHODS:PubMed, Embase, PsycInfo, Cochrane Central Register of Clinical Trials, and Web of Science were queried using multiple OUD-related MESH terms, without date limitations, for English-language publications. Inclusions were human subjects, treatment of OUD, OUD patient or community-level outcomes, and systematic reviews of OUD interventions. Exclusions were laboratory studies, reviews, and case reports. Two reviewers independently scanned abstracts for inclusion before coding eligible full-text articles by pre-specified filters: research design, study population, study setting, intervention, outcomes, sample size, study duration, geographical region, and funding sources. RESULTS:The OUD Evidence Map (https://med.nyu.edu/research/lee-lab/research/opioid-use-disorder-treatment-evidence-map) identified and assessed 12,933 relevant abstracts through 2020. We excluded 9455 abstracts and full text reviewed 2839 manuscripts; 888 were excluded, 1591 were included in the final evidence map. The most studied OUD interventions were methadone (n = 754 studies), buprenorphine (n = 499), and naltrexone (n = 134). The most common outcomes were heroin/opioid use (n = 708), treatment retention (n = 557), and non-opioid drug use (n = 368). Clear gaps included a wider array of opioid agonists for treatment, digital behavioral interventions, studies of OUD treatments in criminal justice settings, and overdose as a clinical outcome. CONCLUSION/CONCLUSIONS:This OUD Evidence Map highlights the importance of pharmacologic interventions for OUD and reductions in opioid use. Future iterations will update results annually and scan policy-level interventions.
PMID: 36332588
ISSN: 1879-0046
CID: 5358852
Methamphetamine/amphetamine use over time among persons with opioid use disorders treated with buprenorphine/naloxone versus extended-release naltrexone
Tsui, Judith I; Campbell, Aimee N C; Pavlicova, Martina; Choo, Tse-Hwei; Lee, Joshua D; Cook, Ryan R; Shulman, Matisyahu; Nunes, Edward V; Rotrosen, John
BACKGROUND:Methamphetamine use is increasing among persons with opioid use disorder (OUD). The study aims were to describe methamphetamine/amphetamine (MA/A) use among patients treated for OUD with buprenorphine/naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and to explore associations between treatment arm and MA/A use. METHODS:Secondary analysis of data from a multi-site, open-label, randomized controlled trial of XR-NTX versus BUP-NX for 24 weeks. The outcome variable was MA/A use defined by either positive urine drug toxicology or self-report. The main predictor was treatment assignment (BUP-NX v. XR-NTX). Longitudinal mixed-effects logistic regression models were fit to model the odds of MA/A use during the study. Additional predictors included study visit and baseline MA/A use. RESULTS:Among the sample of 570 participants with OUD, baseline use of MA/A was observed in 105 (18.4%). There was no significant treatment effect over the study period, though BUP-NX subjects, on average, had about half the odds of MA/A use compared to XR-NTX subjects (OR=0.50; p = 0.051). In the same model, baseline MA/A use and study visit were both significantly associated with MA/A use over time. CONCLUSION:In this sample of treated OUD patients, nearly a fifth of participants had MA/A use at baseline and the frequency of use did not decline over time: in fact, the odds of use slightly increased for each later visit. These secondary analyses found no significant difference in MA/A use between BUP-NX and XR-NTX treatment arms, however, the observation of less MA/A in the buprenorphine arm merits further investigation. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov (NCT02032433).
PMCID:10796081
PMID: 35605529
ISSN: 1879-0046
CID: 5791702
Polysubstance use before and during treatment with medication for opioid use disorder: Prevalence and association with treatment outcomes
Bunting, Amanda M; Krawczyk, Noa; Choo, Tse-Hwei; Pavlicova, Martina; McNeely, Jennifer; Tofighi, Babak; Rotrosen, John; Nunes, Edward; Lee, Joshua D
OBJECTIVE:Polysubstance use may complicate treatment outcomes for individuals who use opioids. This research aimed to examine the prevalence of polysubstance use in an opioid use disorder treatment trial population and polysubstance use's association with opioid relapse and craving. METHODS:This study is a secondary data analysis of individuals with opioid use disorder who received at least one dose of medication (n = 474) as part of a 24-week, multi-site, open label, randomized Clinical Trials Network study (CTN0051, X:BOT) comparing the effectiveness of extended-release naltrexone versus buprenorphine. Models examined pretreatment polysubstance use and polysubstance use during the initial 4 weeks of treatment on outcomes of relapse by week 24 of the treatment trial and opioid craving. RESULTS:Polysubstance use was generally not associated with treatment outcomes of opioid relapse and craving. Proportion of days of pretreatment sedative use was associated with increased likelihood of opioid relapse (OR: 1.01, 95 % CI: 1.00-1.02). Proportion of days of cocaine use during the initial 4 weeks of treatment was associated with increased likelihood of opioid relapse (OR: 1.05, 95 % CI: 1.01-1.09) but this effect was no longer significant once the potential of confounding by opioid use was considered. Sedative use during initial 4 weeks of treatment was associated with increased opioid craving (b: 0.77, 95 % CI: 0.01-1.52). The study found no other significant relationships. CONCLUSIONS:In the current study population, polysubstance use was only marginally associated with 24-week treatment outcomes.
PMID: 35773113
ISSN: 1873-6483
CID: 5281372
Commentary on Ajazi et al (2021) Re-analysis of the X:BOT Trial
Lee, Joshua D; Nunes, Edward V; Novo, Patricia; May, Jeanine; Matthews, Abigail; Van Veldhuisen, Paul; Lindblad, Robert; Liu, David; Rotrosen, John
PMCID:9375053
PMID: 35960212
ISSN: 1935-3227
CID: 5287342
Injecting Opioid Use Disorder Treatment in Jails and Prisons: The Potential of Extended-release Buprenorphine in the Carceral Setting
Berk, Justin; Del Pozo, Brandon; Rich, Josiah D; Lee, Joshua D
As the opioid overdose cases rise, policy-makers and researchers should target interventions to populations at highest risk. Incarceration serves as a risk factor for opioid overdose (Gan et al. Addiction 2021) and a large portion of recent overdose deaths have had encounters in the criminal justice system. Medications for opioid use disorder in the criminal justice system can save lives, though unique administrative barriers in jails and prisons hinder access. As facilities expand medications for opioid use disorder access (due to new legislation and court rulings across states), extended-release buprenorphine offers an opportunity to overcome these barriers including logistics of administration, diversion concern, patient stigma, and an increased bridge of treatment during re-entry to the community. As extended-release buprenorphine has practical advantages in correctional health delivery, future research and policy discussions should investigate its optimal role in treating opiate addiction in a carceral setting.
PMID: 34954747
ISSN: 1935-3227
CID: 5107942
Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study
Cheng, Anna; Badolato, Ryan; Segoshi, Andrew; McDonald, Ryan; Malone, Mia; Vasudevan, Kumar; Badiei, Beita; Sugarman, Allison; Macdonald, Ross; Mangat, Jasdeep; Giftos, Jonathan; Lee, Joshua D; Tofighi, Babak
BACKGROUND:Extended-release buprenorphine (XRB) offers a novel approach to sustained monthly treatment for people who use opioids in criminal justice settings (CJS). This study explores the experiences of adults receiving XRB as a jail-to-community treatment. METHODS AND FINDINGS:In-depth qualitative interviews were conducted among adult participants with opioid use disorder (OUD; n  = 16) who were recently released from NYC jails and maintained on XRB after switching from daily sublingual buprenorphine (SLB). Interviews elaborated on the acceptability and barriers and facilitators of XRB treatment pre- and post-release. Interviews were audio recorded, transcribed, and analyzed for content related to factors influencing XRB treatment uptake and community reentry. Important themes were grouped into systems, medication, and patient-level factors. Key systems-level factors influencing initiation of XRB in jail included an alternative to perceived stigmatization and privacy concerns associated with daily in-jail SLB administration and less concerns with buprenorphine diversion. In-jail peer networks positively influenced participant adoption of XRB. XRB satisfaction was attributed to reduced in-jail clinic and medication administration visits, perceived efficacy and blockade effects upon the use of heroin/fentanyl following release, and averting the risk of criminal activities to fund opioid use. Barriers to retention included post-injection withdrawal symptoms and cravings attributed to perceived suboptimal medication dosing, injection site pain, and lack of in-jail provider information about the medication. CONCLUSION:Participants were generally favorable to XRB initiation in jail and retention post-release. Further studies are needed to address factors influencing access to XRB in criminal justice settings, including stigma, ensuring patient privacy following initiation on XRB, and patient-, provider-, and correctional staff education pertaining to XRB. Trial Registration ClinicalTrials.gov Identified: NCT03604159.
PMCID:8800291
PMID: 35093164
ISSN: 1940-0640
CID: 5153262
Patient Characteristics Associated with Opioid Abstinence after Participation in a Trial of Buprenorphine versus Injectable Naltrexone
Greiner, Miranda G; Shulman, Matisyahu; Scodes, Jennifer; Choo, Tse-Hwei; Pavlicova, Martina; Opara, Onumara; Campbell, Aimee N C; Novo, Patricia; Fishman, Marc; Lee, Joshua D; Rotrosen, John; Nunes, Edward V
PMID: 35975917
ISSN: 1532-2491
CID: 5299932