Dataset Information

Improving Translational Research Outcomes for Opioid Use Disorder Treatments.

ABSTRACT:

Purpose of review

Pharmacotherapies are the most effective means of reducing the harms associated with opioid use disorder (OUD). Translational research seeking to develop novel medications to treat OUD has been challenging due to the complex etiology of addiction. Preclinical outcome measures are often behavioral, and it is difficult, if not impossible, to fully mirror the various emotional and cognitive processes that motivate opioid use in humans. The goal of the current narrative review was to summarize the translational progression of three potential medications for OUD, which had varying levels of success.

Recent findings

Memantine, lorcaserin, and lofexidine all showed promise in preclinical studies; however, only lofexidine was able to consistently replicate these findings in human subjects, and receive FDA approval. It was the authors' objective to use this review to identify areas of needed improvement in translational research for OUD.

Summary

Preclinical studies vary significantly in their ability to forecast effectiveness in clinical trials. Among the various preclinical models, suppression of opioid self-administration appears to have the best predictive validity. As they model a mostly physiological phenomenon, preclinical assessments of opioid withdrawal also appear to have high predictive validity. In our review of the literature, the authors noted numerous examples of clinical trials that were underpowered, lack precision, and proper outcomes. Better-validated preclinical targets and improved design of proof-of-concept human studies should allow investigators to more efficiently develop and test medications for OUD.

SUBMITTER: Jones JD

PROVIDER: S-EPMC10299742 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Improving Translational Research Outcomes for Opioid Use Disorder Treatments.

Jones Jermaine D JD Varshneya Neil B NB Hudzik Thomas J TJ Huhn Andrew S AS

Current addiction reports 20210112 1

<h4>Purpose of review</h4>Pharmacotherapies are the most effective means of reducing the harms associated with opioid use disorder (OUD). Translational research seeking to develop novel medications to treat OUD has been challenging due to the complex etiology of addiction. Preclinical outcome measures are often behavioral, and it is difficult, if not impossible, to fully mirror the various emotional and cognitive processes that motivate opioid use in humans. The goal of the current narrative rev ...[more]

PMID: 37377692

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Project description:ImportanceAgonist medications for opioid use disorder (MOUD), buprenorphine and methadone, in carceral settings might reduce the risk of postrelease opioid overdose but are uncommonly offered. In April 2019, the Massachusetts Department of Correction (MADOC), the state prison system, provided buprenorphine for incarcerated individuals in addition to previously offered injectable naltrexone.ObjectiveTo evaluate postrelease outcomes after buprenorphine implementation.Design, setting, and participantsThis cohort study with interrupted time-series analysis used linked data across multiple statewide data sets in the Massachusetts Public Health Data Warehouse stratified by sex due to differences in carceral systems. Eligible participants were individuals sentenced and released from a MADOC facility to the community. The study period for the male sample was January 2014 to November 2020; for the female sample, January 2015 to October 2019. Data were analyzed between February 2022 and January 2024.ExposureApril 2019 implementation of buprenorphine during incarceration.Main outcomes and measuresReceipt of MOUD within 4 weeks after release, opioid overdose, and all-cause mortality within 8 weeks after release, each measured as a percentage of monthly releases who experienced the outcome. Segmented linear regression analyzed changes in outcome rates after implementation.ResultsA total of 15 225 individuals were included. In the male sample there were 14 582 releases among 12 688 individuals (mean [SD] age, 35.0 [10.8] years; 133 Asian and Pacific Islander [0.9%], 4079 Black [28.0%], 4208 Hispanic [28.9%], 6117 White [41.9%]), a rate of 175.7 releases per month; the female sample included 3269 releases among 2537 individuals (mean [SD] age, 34.9 [9.8] years; 328 Black [10.0%], 225 Hispanic [6.9%], 2545 White [77.9%]), a rate of 56.4 releases per month. Among male participants at 20 months postimplementation, the monthly rate of postrelease buprenorphine receipt was higher than would have been expected under baseline trends (21.2% vs 10.6% of monthly releases; 18.6 additional releases per month). Naltrexone receipt was lower than expected (1.0% vs 6.0%; 8.8 fewer releases per month). Monthly rates of methadone receipt (1.4%) and opioid overdose (1.8%) were not significantly different than expected. All-cause mortality was lower than expected (1.9% vs 2.8%; 1.5 fewer deaths per month). Among female participants at 7 months postimplementation, buprenorphine receipt was higher than expected (31.6% vs 9.5%; 12.4 additional releases per month). Naltrexone receipt was lower than expected (3.4% vs 7.2%) but not statistically significantly different. Monthly rates of methadone receipt (1.1%), opioid overdose (4.8%), and all-cause mortality (1.6%) were not significantly different than expected.Conclusions and relevanceIn this cohort study of state prison releases, postrelease buprenorphine receipt increased and naltrexone receipt decreased after buprenorphine became available during incarceration.

Project description:AimTo investigate the real-world effectiveness of pharmacological treatments (buprenorphine, methadone) of opioid use disorder (OUD).DesignA nation-wide, register-based cohort study.SettingSweden.ParticipantsAll residents aged 16-64 years living in Sweden using OUD medication from July 2005 to December 2016 (n = 5757, 71.8% men) were identified from registers of prescriptions, inpatient and specialized outpatient care, causes of death, sickness absence and disability pensions.MeasurementsMain outcome: hospitalization due to OUD.Secondary outcomeshospitalization due to any cause; death due to all, natural and external causes. Mortality was analyzed with between-individual multivariate-adjusted Cox hazards regression model. Recurrent outcomes, such as hospitalizations, were analyzed with within-individual analyses to eliminate selection bias. OUD medication use versus non-use was modelled with PRE2DUP (from prescription drug purchases to drug use periods) method.FindingsBuprenorphine [hazard ratio (HR) = 0.73, 95% confidence interval (CI) = 0.54-0.97] and methadone (HR = 0.74, 95% CI = 0.59-0.93) use were associated with significantly lower risk of OUD hospitalization, but not any-cause hospitalizations, compared with the time-periods when the same individual did not use OUD medication. The use of buprenorphine and methadone were both associated with significantly lower risk of all-cause mortality (HR = 0.45, 95% CI = 0.34-0.59; HR = 0.51, 95% CI = 0.41-0.63, respectively), compared with non-use of both medications. Similar results were found for risk of mortality due to external causes (HR = 0.39; 95% CI = 0.27-0.54; HR = 0.40; 95% CI = 0.29-0.53, respectively), but not for mortality due to natural causes. The risk of OUD hospitalization and all-cause mortality was decreased in all duration categories of studied medications (< 30, 31-180, 181-365 and >365 days), except for methadone use less than 30 days.ConclusionsThe use of buprenorphine and methadone are both associated with a significantly lower risk of hospitalization due to opioid use disorder and death due to all and external causes, when compared with non-use.

Project description:AimTo test the effect of the duration of medication for opioid use disorder (MOUD) use during pregnancy on maternal, perinatal and neonatal outcomes.DesignRetrospective cohort analysis of claims, encounter and pharmacy data.SettingPennsylvania, USA.ParticipantsWe analyzed 13 320 pregnancies among 10 741 women with opioid use disorder aged 15-44 years enrolled in Pennsylvania Medicaid between 2009 and 2017.MeasurementsWe examined five outcomes during pregnancy and for 12 weeks postpartum: (1) overdose, (2) postpartum MOUD continuation, (3) preterm birth (< 37 weeks gestation), (4) term low birth weight (< 2500 g at ≥ 37 weeks) and (5) neonatal abstinence syndrome (NAS). Our primary exposure was the duration (count of weeks) of any MOUD use, including methadone or buprenorphine, during pregnancy.FindingsAmong 13 320 pregnancies, 306 (2.3%) were complicated by an overdose, 1753 (13.2%) resulted in a preterm birth and 6787 (50.9%) continued MOUD postpartum. Among infants, 874 (7.6%) were low birth weight at term and 7706 (57.9%) were diagnosed with NAS. As the duration of MOUD use increased, we found a statistically significant decrease in the rate of overdose and preterm birth, a statistically significant increase in the rate of postpartum MOUD continuation and NAS and a decline in term low birth weight. Specifically, for each additional week of MOUD, the adjusted odds of overdose decreased by 2% [adjusted odds ratio (aOR) = 0.98; 95% confidence interval (CI) = 0.97, 0.99], preterm birth decreased by 1% (aOR = 0.99; 95% CI = 0.99, 1.00), postpartum MOUD continuation increased by 95% (aOR = 1.95; 95% CI = 1.87, 2.04) and NAS increased by 41% (aOR = 1.41; 95% CI = 1.35, 1.47). The odds of term low birth weight did not change (aOR = 1.00; 95% CI = 0.99, 1.00), although the rate declined with a longer duration of MOUD use during pregnancy.ConclusionsLonger duration of medication for opioid use disorder use during pregnancy appears to be associated with improved maternal and perinatal outcomes.

Project description:BackgroundGaps in electronic health record (EHR) data collection and the paucity of standardized clinical data elements (CDEs) captured from electronic and digital data sources have impeded research efforts aimed at understanding the epidemiology and quality of care for opioid use disorder (OUD). We identified existing CDEs and evaluated their validity and usability, which is required prior to infrastructure implementation within EHRs.MethodsWe conducted (a) a systematic literature review of publications in Medline, Embase and the Web of Science using a combination of at least one term related to OUD and EHR and (b) an environmental scan of publicly available data systems and dictionaries used in national informatics and quality measurement of policy initiatives. Opioid-related data elements identified within the environmental scan were compared with related data elements contained within nine common health data code systems and each element was graded for alignment with match results categorized as "exact", "partial", or "none."ResultsThe literature review identified 5186 articles for title search, of which 75 abstracts were included for review and 38 articles were selected for full-text review. Full-text articles yielded 237 CDEs, only 12 (5.06%) of which were opioid-specific. The environmental scan identified 379 potential data elements and value sets across 9 data systems and libraries, among which only 84 (22%) were opioid-specific. We found substantial variability in the types of clinical data elements with limited overlap and no single data system included CDEs across all major data element types such as substance use disorder, OUD, medication and mental health. Relative to common health data code systems, few data elements had an exact match (< 1%), while 61% had a partial match and 38% had no matches.ConclusionsDespite the increasing ubiquity of EHR data standards and national attention placed on the opioid epidemic, we found substantial fragmentation in the design and construction of OUD related CDEs and little OUD specific CDEs in existing data dictionaries, systems and literature. Given the significant gaps in data collection and reporting, future work should leverage existing structured data elements to create standard workflow processes to improve OUD data capture in EHR systems.

Dataset Information

Improving Translational Research Outcomes for Opioid Use Disorder Treatments.

Purpose of review

Recent findings

Summary

Publications

Improving Translational Research Outcomes for Opioid Use Disorder Treatments.

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