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Journal ArticleDOI

Opioid substitution and antagonist therapy trials exclude the common addiction patient: a systematic review and analysis of eligibility criteria

TL;DR: Trials assessing OSATs often exclude patients with concurrent disorders, and results from these trials are likely to overestimate the true effectiveness of OSats, so North American guidelines should consider these limitations when drafting clinical recommendations.
Abstract: Eligibility criteria that result in the exclusion of a substantial number of patients from randomized trials jeopardize the generalizability of treatment effect to much of the clinical population. This is important when evaluating opioid substitution and antagonist therapies (OSATs), especially given the challenges associated with treating the opioid-dependent population. We aimed to identify OSAT trials' eligibility criteria, quantify the percentage of the clinical population excluded by these criteria, and determine how OSAT guidelines incorporate evidence from these trials. We performed a systematic review to identify the eligibility criteria used across trials. We searched Medline, EMBASE, PsycINFO, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry (CTR), World Health Organization International CTR Platform Search Portal, and the National Institutes of Health CTR databases from inception to January 1, 2014. To quantify the effect of trials' eligibility criteria on generalizability, we applied these criteria to data from an observational study of opioid-dependent patients (n = 394). We then accessed the Canadian, American, British, and World Health Organization (WHO) OSAT guidelines to evaluate how evidence is used in the recommendations. Among the 60 trials identified the majority (≥50 % of trials) exclude patients with psychiatric (60 %) and physical comorbidity (51.7 %). Additionally, we found 19 trials exclude patients with current alcohol/substance-use problems (31.7 %), and 29 (48.3 %) exclude patients taking psychotropic medications. These criteria were restrictive and in some cases rendered 70 % of the observational sample ineligible. North American OSAT guidelines made strong recommendations supported by evidence with poor generalizability. National Institute of Health and Care Excellence (NICE) and WHO guidelines for opioid misuse provide a critical assessment of the literature used to inform their recommendations. Trials assessing OSATs often exclude patients with concurrent disorders. If the excluded patients respond differently to treatment, results from these trials are likely to overestimate the true effectiveness of OSATs. North American guidelines should consider these limitations when drafting clinical recommendations.

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Citations
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Journal ArticleDOI
TL;DR: Many individuals intending to start extended-release naltrexone (XR-NTX) do not and most who do start XR- NTX discontinue treatment prematurely, two factors that limit its clinical utility significantly.
Abstract: Aims To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined. Methods We searched PubMed and used Google Scholar for forward citation searches of peer-reviewed papers from January 2006 to June 2017. Studies that included individuals seeking treatment for opioid use disorder who were offered XR-NTX were included. Results We identified and included 34 studies. Pooled estimates showed that XR-NTX induction success was lower in studies that included individuals that required opioid detoxification [62.6%, 95% confidence interval (CI) = 54.5-70.0%] compared with studies that included individuals already detoxified from opioids (85.0%, 95% CI = 78.0-90.1%); 44.2% (95% CI = 33.1-55.9%) of individuals took all scheduled injections of XR-NTX, which were usually six or fewer. Adherence was higher in prospective investigational studies (i.e. studies conducted in a research context according to a study protocol) compared to retrospective studies of medical records taken from routine care (6-month rates: 46.7%, 95% CI = 34.5-59.2% versus 10.5%, 95% CI = 4.6-22.4%, respectively). Compared with referral to treatment, XR-NTX reduced opioid use in adults under criminal justice supervision and when administered to inmates before release. XR-NTX reduced opioid use compared with placebo in Russian adults, but this effect was confounded by differential retention between study groups. XR-NTX showed similar efficacy to buprenorphine when randomization occurred after detoxification, but was inferior to buprenorphine when randomization occurred prior to detoxification. Conclusions Many individuals intending to start extended-release naltrexone (XR-NTX) do not and most who do start XR-NTX discontinue treatment prematurely, two factors that limit its clinical utility significantly. XR-NTX appears to decrease opioid use but there are few experimental demonstrations of this effect.

140 citations


Cites background from "Opioid substitution and antagonist ..."

  • ...The reasons for this large divergence are unclear, but may include differences between samples owing to study exclusion criteria [73,74] and a host of procedural differences between investigational studies and routine clinical care (e....

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Journal ArticleDOI
TL;DR: Medications currently used to treat alcohol and opioid use disorders also appear to reduce suicidality and crime during treatment, and are associated with reduced arrest rates for all crime categories.
Abstract: Objective:The authors examined associations between medications for alcohol and opioid use disorders (acamprosate, naltrexone, methadone, and buprenorphine) and suicidal behavior, accidental overdo...

44 citations


Cites background from "Opioid substitution and antagonist ..."

  • ...Furthermore, many randomized controlled trials have limited generalizability to real-world practice, because they often exclude patients who have comorbid psychiatric disorders (13)....

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Journal ArticleDOI
TL;DR: The study provides further evidence for the efficacy and safety of maintenance treatment with opioid agonists and changes in concomitant drug use and somatic and mental health.
Abstract: Background: In many countries, the opioid agonists, buprenorphine and methadone, are licensed for maintenance treatment of opioid dependence. Many short-term stud

44 citations

Journal ArticleDOI
10 Apr 2016
TL;DR: This study helps to identify patients at increased risk of relapse during MMT, allowing health care providers to target more aggressive adjunct therapies toward high-risk patients.
Abstract: Introduction: Concomitant opioid abuse is a serious problem among patients receiving methadone maintenance treatment (MMT) for opioid use disorder. This is an exploratory study that aims to identify predictors of the length of time a patient receiving MMT for opioid use disorder remains abstinent (relapse-free). Methods: Data were collected from 250 MMT patients enrolled in addiction treatment clinics across Southern Ontario. The impact of certain clinical and socio-demographic factors on the outcome (time until opioid relapse) was determined using a Cox proportional hazard model. Results: History of injecting drug use behavior (hazard ratio (HR): 2.26, P = 0.042), illicit benzodiazepine consumption (HR: 1.07, P = 0.002), and the age of onset of opioid abuse (HR: 1.10, P < 0.0001) are important indicators of accelerated relapse among MMT patients. Conversely, current age is positively associated with duration of abstinence from illicit opioid use, serving as a protective factor against relapse (HR: 0.93, P = 0.003). Conclusion: This study helps to identify patients at increased risk of relapse during MMT, allowing health care providers to target more aggressive adjunct therapies toward high-risk patients.

35 citations

Journal ArticleDOI
TL;DR: Clinical evidence is provided revealing that 82% of patients with high-risk diabetes had SUD and/or MHD recorded in their EHRs, highlighting a need for developing service models to optimize high- risk care.

27 citations


Cites background from "Opioid substitution and antagonist ..."

  • ...Such high-need, medically comorbid or unstable populations are typically excluded from national surveys of BHDs in the general, non-institutionalized population and clinical trials due to safety consideration or study-specific exclusion criteria (Dennis et al., 2015; Lind, 2011)....

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References
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Journal ArticleDOI
Jacob Cohen1
TL;DR: In this article, the authors present a procedure for having two or more judges independently categorize a sample of units and determine the degree, significance, and significance of the units. But they do not discuss the extent to which these judgments are reproducible, i.e., reliable.
Abstract: CONSIDER Table 1. It represents in its formal characteristics a situation which arises in the clinical-social-personality areas of psychology, where it frequently occurs that the only useful level of measurement obtainable is nominal scaling (Stevens, 1951, pp. 2526), i.e. placement in a set of k unordered categories. Because the categorizing of the units is a consequence of some complex judgment process performed by a &dquo;two-legged meter&dquo; (Stevens, 1958), it becomes important to determine the extent to which these judgments are reproducible, i.e., reliable. The procedure which suggests itself is that of having two (or more) judges independently categorize a sample of units and determine the degree, significance, and

34,965 citations


"Opioid substitution and antagonist ..." refers background or methods in this paper

  • ...We used the kappa statistic to assess inter-rater agreement, [43], which is preferable to percent agreement calculations since it takes into account any agreement occurring by chance....

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  • ...Kappa values range from 0 to 1, with values closer to 1 indicating a higher level of agreement [43]....

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Journal ArticleDOI
TL;DR: An Explanation and Elaboration of the PRISMA Statement is presented and updated guidelines for the reporting of systematic reviews and meta-analyses are presented.
Abstract: Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

25,711 citations


"Opioid substitution and antagonist ..." refers methods in this paper

  • ...This review adheres to the reporting standards set out by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines [44]....

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Journal Article
TL;DR: The Mini-International Neuropsychiatric Interview is designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings.
Abstract: The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, developed jointly by psychiatrists and clinicians in the United States and Europe, for DSM-IV and ICD-10 psychiatric disorders. With an administration time of approximately 15 minutes, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies and to be used as a first step in outcome tracking in nonresearch clinical settings. The authors describe the development of the M.I.N.I. and its family of interviews: the M.I.N.I.-Screen, the M.I.N.I.-Plus, and the M.I.N.I.-Kid. They report on validation of the M.I.N.I. in relation to the Structured Clinical Interview for DSM-III-R, Patient Version, the Composite International Diagnostic Interview, and expert professional opinion, and they comment on potential applications for this interview.

19,347 citations


"Opioid substitution and antagonist ..." refers methods in this paper

  • ...(MINI) [47] to assess for psychiatric comorbidities, and the Maudsley Addiction Profile (MAP) instrument to...

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  • ...Changes made following the pilot phase include: relaxing eligibility criteria, utilizing a prospective cohort design with a follow-up duration of 12 months, and integrating the use of validated tools such as the Brief Pain Inventory (BPI) to assess pain [46], the Mini International Neuropsychiatric Interview version 6.0 (MINI) [47] to assess for psychiatric comorbidities, and the Maudsley Addiction Profile (MAP) instrument to assess addiction severity across personal, physical, and social functioning domains [48]....

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  • ...Depending on the thoroughness of the trial investigators and indeed the thoroughness of the clinicians administering the GENOA assessment tools (MINI, BPI, MAP), differing rates of psychiatric problems will be identified and could compromise the aims of our study....

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  • ...However, we maintain important variables, such as psychiatric comorbidity, were ascertained using a validated questionnaire, the MINI....

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  • ...(PDF 262 kb) Abbreviations AGREE: Appraisal of Guidelines for Research and Evaluation; ASI: Addiction Severity Index; BPI: Brief Pain Inventory; CATC: Canadian Addiction Treatment Centres; CI: confidence interval; CTR: Clinical Trials Registry; DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; EMBASE: Excerpta Medica DataBase; FDA: Food and Drug Administration; GENOA: Genetics of Opioid Addiction; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HIV: human immunodeficiency virus; HR: hazard ratio; ICD: International Classification of Disease; LAAM: levo-α-acetylmethadol; MAP: Maudsley Addiction Profile; MINI: The Mini International Neuropsychiatric Interview; MMT: methadone maintenance treatment; NICE: National Institute for Health and Care Excellence; NIH: National Institutes of Health; OATC: Ontario Addiction Treatment Centres; OSAT: opioid substitution and antagonist therapy; OST: opioid substitution therapy; PRISMA: Preferred Reporting Items for Systematic reviews and Meta-Analyses; RCT: randomized controlled trial; SD: standard deviation; SE: standard error; WHO: World Health Organization; UK: United Kingdom; US: United States....

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Journal ArticleDOI
21 Jul 2009-BMJ
TL;DR: The meaning and rationale for each checklist item is explained, and an example of good reporting is included and, where possible, references to relevant empirical studies and methodological literature are included.
Abstract: Systematic reviews and meta-analyses are essential to summarise evidence relating to efficacy and safety of healthcare interventions accurately and reliably. The clarity and transparency of these reports, however, are not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (quality of reporting of meta-analysis) statement—a reporting guideline published in 1999—there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realising these issues, an international group that included experienced authors and methodologists developed PRISMA (preferred reporting items for systematic reviews and meta-analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this explanation and elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA statement, this document, and the associated website (www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

13,813 citations


"Opioid substitution and antagonist ..." refers methods in this paper

  • ...This review adheres to the reporting standards set out by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines [44]....

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