scholarly journals A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Brittany B. Dennis ◽  
Nitika Sanger ◽  
Monica Bawor ◽  
Leen Naji ◽  
Carolyn Plater ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Addiction Treatment ◽  
Treatment Effectiveness ◽  
Methadone Treatment ◽  
Population Level ◽  
Opioid Addiction ◽  
Complex Nature ◽  
Opioid Use ◽  
Structured Interviews ◽  
Patient Reported

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g., EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient-reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g., abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n = 28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, although they also stressed goals under-reported in clinical trials. Conclusions There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. Trial registration PROSPERO, CRD42013006507.

scholarly journals Full A Call for Consensus in Defining Efficacy in Clinical Trials for Opioid Addiction: Combined Results from a Systematic Review and Qualitative Study in Patients Receiving Pharmacological Assisted Therapy for Opioid Use Disorder

2019 ◽  
Author(s):  
Brittany B. Dennis ◽  
Nitika Sanger ◽  
Monica Bawor ◽  
Leen Naji ◽  
Andrew Worster ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Addiction Treatment ◽  
Treatment Effectiveness ◽  
Methadone Treatment ◽  
Population Level ◽  
Opioid Addiction ◽  
Complex Nature ◽  
Opioid Use ◽  
Structured Interviews ◽  
Patient Reported

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms.We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g. EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g. abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n=28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, however they also stressed goals under-reported in clinical trials. Conclusion There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. PROSPERO ID CRD42013006507

scholarly journals A Call for Consensus in Defining Efficacy in Clinical Trials for Opioid Addiction: Combined Results from a Systematic Review and Qualitative Study in Patients Receiving Pharmacological Assisted Therapy for Opioid Use Disorder

2019 ◽  
Author(s):  
Brittany B. Dennis ◽  
Nitika Sanger ◽  
Monica Bawor ◽  
Leen Naji ◽  
Andrew Worster ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Addiction Treatment ◽  
Treatment Effectiveness ◽  
Methadone Treatment ◽  
Population Level ◽  
Opioid Addiction ◽  
Complex Nature ◽  
Opioid Use ◽  
Structured Interviews ◽  
Patient Reported

Abstract Background: Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms. We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods: We searched nine commonly used databases (e.g. EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results: We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g. abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n=28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, however they also stressed goals under-reported in clinical trials. Conclusion: There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. PROSPERO ID: CRD42013006507 Key Words: opioid addiction; clinical trials; efficacy; methodology; patient important outcomes; treatment effectiveness

scholarly journals A Call for Consensus in Defining Efficacy in Clinical Trials for Opioid Addiction: Combined Results from a Systematic Review and Qualitative Study in Patients Receiving Pharmacological Assisted Therapy for Opioid Use Disorder

2019 ◽  
Author(s):  
Brittany B. Dennis ◽  
Nitika Sanger ◽  
Monica Bawor ◽  
Leen Naji ◽  
Andrew Worster ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Addiction Treatment ◽  
Treatment Effectiveness ◽  
Methadone Treatment ◽  
Population Level ◽  
Opioid Addiction ◽  
Complex Nature ◽  
Opioid Use ◽  
Structured Interviews ◽  
Patient Reported

Abstract Background Given the complex nature of opioid addiction treatment and the rising number of available opioid substitution and antagonist therapies (OSAT), there is no ‘gold standard’ measure of treatment effectiveness, and each successive trial measures a different set of outcomes which reflect success in arbitrary or opportune terms.We sought to describe the variation in current outcomes employed across clinical trials for opioid addiction, as well as determine whether a discrepancy exists between the treatment targets that patients consider important and how treatment effectiveness is measured in the literature. Methods We searched nine commonly used databases (e.g. EMBASE, MEDLINE) from inception to August 1, 2015. Outcomes used across trials were extracted and categorized according to previously established domains. To evaluate patient reported goals of treatment, semi-structured interviews were conducted with 18 adults undergoing methadone treatment. Results We identified 60 trials eligible for inclusion. Once outcomes were categorized into eight broad domains (e.g. abstinence/substance abuse), we identified 21 specific outcomes with furthermore 53 subdomains and 118 measurements. Continued opioid use and treatment retention were the most commonly reported measures (46%, n=28). The majority of patients agreed that abstinence from opioids was a primary goal in their treatment, however they also stressed goals under-reported in clinical trials. Conclusion There is inconsistency in the measures used to evaluate the effectiveness of OSATs. Individual and population level decision making is being guided by a standard of effect considered useful to researchers yet in direct conflict with what patients deem important. PROSPERO ID CRD42013006507

Addiction Treatment as Prison Governance: A Critical Discourse Analysis of Methadone Delivery in Kyrgyz Prisons

2021 ◽  
pp. 009145092110607 ◽  
Author(s):  
Lyu Azbel ◽  
Daniel J. Bromberg ◽  
Sergii Dvoryak ◽  
Frederick L. Altice
Keyword(s):  
Eastern Europe ◽  
Central Asia ◽  
Critical Discourse Analysis ◽  
Addiction Treatment ◽  
Methadone Treatment ◽  
Opioid Addiction ◽  
Kyrgyz Republic ◽  
Opioid Use ◽  
Informal Governance ◽  
The Government

Methadone treatment is prescribed by evidence-based medicine as the most effective tool for the treatment of opioid addiction. Its implementation into high-need prison settings worldwide has been met with challenges, particularly in Eastern Europe and Central Asia where the opioid epidemic continues to expand. To address these impasses to intervention translation, we turn to post-structural approaches to policy analysis. These approaches open space for (re)thinking the ways that translated interventions emerge locally, by treating policy texts as social practices that make interventions in specific, sometimes unexpected, ways. We leverage Carol Bacchi’s post-structuralist analytic framework to interrogate how the object of methadone is constituted in Kyrgyz prisons through an analysis of the national legislative document, the “Government Program,” which provides the legislative basis for opioid addiction treatment administration in the Kyrgyz Republic. Rather than the medicalized methadone for the treatment of opioid use disorder, contained in the distinct objectivization of methadone emerging from this policy text, is the previously unexamined assumption that methadone is a particular type of governance. We describe a methadone object tied up with the shifting social structures that govern Kyrgyz prisons, divided between formal (state-run) and informal (prisoner-run) governance. In Kyrgyz prisons, where opioid policy discourse produces a divide between formal and informal governance, methadone emerges as a tool of the formal prison administration to regain control of the prisons from the practices of prisoner subculture. Although this study takes the Kyrgyz case as an example, the enactment of methadone as formal governance is likely to resonate throughout Eastern Europe and Central Asia, where there is a strong legacy of self-governing prisons. We conclude with a call for global health policymakers to consider how opioid addiction treatment is constituted within local governing relations, in ways that may depart sharply from the evidence base.

Efficacy of a password-protected pill-dispensing device to enhance disposal of unused opioids after cancer surgery.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 264-264
Author(s):  
Jacob Cogan ◽  
Melissa Kate Accordino ◽  
Melissa Parsons Beauchemin ◽  
Sophie Ulene ◽  
Elena B. Elkin ◽  
...  
Keyword(s):  
Pain Control ◽  
Cancer Surgery ◽  
High Rate ◽  
Smartphone App ◽  
Opioid Use ◽  
Structured Interviews ◽  
Health Crisis ◽  
Patient Reported ◽  
After Cancer ◽  
The Impact

264 Background: Opioid misuse is a public health crisis. Initial opioid exposures often occur post-operatively, and 10% of opioid-naïve patients who undergo cancer surgery subsequently become long-term opioid users. It has been shown that 70% of opioids prescribed post-operatively go unused, but only 9% of unused pills are disposed appropriately, which increases the risk of unintended use. We evaluated the impact of an inexpensive, password-protected dispensing device with mail return capacity on retrieval of unused pills after cancer surgery. Methods: Adult patients scheduled for major cancer-related surgery were eligible. Enrolled patients received opioid prescriptions in a password-protected, pill-dispensing device (Addinex) from a specialty pharmacy. The mechanical device links to a smartphone app, which provides passwords on a prescriber-defined schedule. Patients request a password when they are in pain, enter the password into the device and receive a pill if the prescribed time has elapsed. The smartphone app provides clinical guidance based on patient-reported pain levels, and suggests tapering strategies. Patients are instructed to return the device in a DEA-approved mailer when opioid use is no longer required for pain control. Unused pills are destroyed upon receipt. The primary objective was to determine the feasibility of device return, defined as > 50% of patients with device return. We also explored patterns of device use, patient reported outcomes, and device satisfaction via surveys and semi-structured interviews. Results: Between October, 2020 and April, 2021, 13 patients completed the study; 4 patients are currently enrolled. Among the initial 13 patients, 7 underwent abdominal hysterectomy, 4 underwent mastectomy and 2 underwent cutaneous tumor resections. The majority of these patients (n = 10, 77%) returned the device, and more than half (n = 7, 54%) returned the device within 6 weeks of surgery. Only a minority of patients (n = 5, 38%) used the device to obtain opioids; most (n = 8, 62%) used no opioids at home, and all of these patients returned the device and the unused pills. Of 11 patients who participated in semi-structured interviews, most (n = 7, 64%) said they felt safer having opioids in the device instead of a regular pill bottle. Among device users, the majority (n = 4, 80%) reported an overall positive experience. All non-users reported having no opioid requirement for pain control. Conclusions: Our early findings suggest that use of an inexpensive, password-protected, pill-dispensing device to assist with opioid dispensing and return is feasible, with a high rate of device and unused opioid return to the pharmacy. This strategy may be effective for reducing opioid diversion. Analyses and recruitment are ongoing to evaluate the benefits of reducing post-operative opioid consumption.

scholarly journals Lofexidine for acute opioid withdrawal: A clinical case series

2020 ◽  
Vol 10 (5) ◽  
pp. 259-263
Author(s):  
Mandy L. Renfro ◽  
Lindsey J. Loera ◽  
Carlos F. Tirado ◽  
Lucas G. Hill
Keyword(s):  
Addiction Treatment ◽  
Case Series ◽  
Retrospective Chart Review ◽  
The United States ◽  
Opioid Withdrawal ◽  
Withdrawal Symptoms ◽  
Total Daily Dose ◽  
Opioid Use ◽  
Management Protocol ◽  
Patient Reported

Abstract Introduction Maintaining abstinence through the opioid withdrawal period is a substantial barrier to treatment for patients with opioid use disorder. The alpha-2 agonist lofexidine has demonstrated efficacy and safety in clinical trials, but pragmatic studies describing its use in clinical practice are lacking. This case series describes the use of lofexidine for opioid withdrawal symptoms in an inpatient addiction treatment facility. Methods Seventeen patients receiving at least 1 dose of lofexidine during inpatient treatment for opioid withdrawal were included in this study. A retrospective chart review was conducted for clinical, subjective, and objective data. Adverse events, total daily dose, clinical opioid withdrawal scale (COWS) scores, vital signs, and reasons for early discontinuation of lofexidine are reported. Results Patients treated with lofexidine experienced mild withdrawal symptoms throughout treatment. Most patients (65%) experienced a decrease in their average daily COWS scores from intake to discharge. Two patients (12%) left treatment against medical advice, and 5 patients (29%) discontinued treatment prior to day 7 due to resolution of symptoms. Average daily blood pressure readings remained stable, and daily average heart rate decreased over time. Discussion Lofexidine can be successfully incorporated into a conventional withdrawal management protocol. The cost of lofexidine and its recent introduction to the market remain barriers to accessibility in the United States. Studies evaluating patient-reported outcomes as well as direct comparisons with other alpha-2 agonists are needed to inform optimal clinical use of lofexidine.

scholarly journals Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study

2015 ◽  
Vol 150 ◽  
pp. 112-119 ◽  
Author(s):  
Roger D. Weiss ◽  
Jennifer Sharpe Potter ◽  
Margaret L. Griffin ◽  
Scott E. Provost ◽  
Garrett M. Fitzmaurice ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Abuse ◽  
Addiction Treatment ◽  
Opioid Addiction ◽  
Prescription Opioid ◽  
Drug Abuse Treatment ◽  
Long Term Outcomes ◽  
National Drug ◽  
Abuse Treatment

scholarly journals Identifying patient-important outcomes in medication-assisted treatment for opioid use disorder patients: a systematic review protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025059 ◽  
Author(s):  
Nitika Sanger ◽  
Hamnah Shahid ◽  
Brittany B Dennis ◽  
Jackie Hudson ◽  
David Marsh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Addiction Treatment ◽  
Treatment Success ◽  
Opioid Use Disorder ◽  
Primary Objective ◽  
Cochrane Library ◽  
Opioid Use ◽  
Medication Assisted Treatment ◽  
Study Results ◽  
Clinical Trials Registry

IntroductionIllicit opioid use has become a national crisis in Canada, with over 65 000 people seeking treatment for opioid use disorder (OUD) in Ontario and British Columbia alone. Medication-assisted treatment (MAT) is a common treatment for OUD. There is substantial variability in treatment outcomes used to evaluate effectiveness of MAT, making it difficult to establish clinically and scientifically relevant treatment effect. Furthermore, patients are often excluded from the process of determining these outcomes. The primary objective of this review is to examine outcomes currently used to measure MAT effectiveness and to identify patient-relevant outcomes to enhance effectiveness of treatment options. This review refers to patient-important outcomes as those outcomes patients consider important to or markers of treatment success.Methods and analysisMEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Cochrane Library, Cochrane Clinical Trials Registry, National Institutes for Health Clinical Trials Registry and WHO International Clinical Trials Registry Platform databases will be searched. We will search databases from inception to the date the search is ran. Studies of interest include those evaluating the effectiveness of MAT for patients with OUD, with or without consultation with patients regarding what they consider to be important as an indicator of treatment success. Results will be analysed using thematic analysis and qualitative analysis where possible. This will result in comprehensive synthesis of all outcomes and measures found related to OUD treatment effectiveness.Ethics and disseminationWe are collaborating with Canadian Addiction Treatment Centres which provide MAT to patients with OUD who will participate in disseminating study results. Dissemination strategies will involve sharing study results through workshops, presentations, peer-reviewed publications, study reports, community presentations and resources in primary care settings.PROSPERO registration numberCRD42018095553.

Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network prescription opioid addiction treatment study

2015 ◽  
Vol 156 ◽  
pp. e236-e237
Author(s):  
Roger Weiss ◽  
Jennifer S. Potter ◽  
Margaret L. Griffin ◽  
Scott Provost ◽  
Garrett Fitzmaurice ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Abuse ◽  
Addiction Treatment ◽  
Opioid Addiction ◽  
Prescription Opioid ◽  
Drug Abuse Treatment ◽  
Long Term Outcomes ◽  
National Drug ◽  
Abuse Treatment

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

2020 ◽  
Vol 41 (03) ◽  
pp. 377-385
Author(s):  
Canhua Xiao ◽  
Newton Hurst ◽  
Benjamin Movsas
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Treatment Effectiveness ◽  
Clinical Decision ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Cancer Type ◽  
Patient Reported ◽  
State Of The Science

AbstractTraditionally, clinicians have assumed the primary responsibility for evaluating disease- and treatment-related outcomes. In the past few decades, however, a series of recommendations and standards promulgated by professional societies and regulatory agencies have resulted in increased use of patient-reported outcome (PRO) measures in cancer clinical trials. PROs, such as quality of life (QOL) measures, are important in establishing overall treatment effectiveness in cancer clinical trials, and they can inform clinical decision making. This article discusses the current state of the science in PRO research for patients with lung cancer, the cancer type with the highest incidence rate and the lowest survival rate worldwide. The discussion focuses on (1) PRO and survival; (2) electronic PRO reporting and interventions; (3) PROs and immunotherapy; (4) PRO, biomarkers, and precision health; (5) key issues in applying PROs in clinical trials; and (6) future directions for research.

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