scholarly journals Extended-release naltrexone versus standard oral naltrexone versus placebo for opioid use disorder: the NEAT three-arm RCT

2019 ◽  
Vol 23 (3) ◽  
pp. 1-72 ◽  
Author(s):  
John Strang ◽  
Michael Kelleher ◽  
Soraya Mayet ◽  
Ed Day ◽  
Jennifer Hellier ◽  
...  
Keyword(s):  
Technology Assessment ◽  
Extended Release ◽  
Outcome Measure ◽  
Health Technology ◽  
Opioid Use Disorder ◽  
Self Report ◽  
Opioid Use ◽  
Heroin Use ◽  
Oral Naltrexone ◽  
Future Work

Background People recovering from heroin addiction need better treatments than are currently offered. The chronic relapsing nature of drug dependence means that helping a patient to achieve abstinence is often difficult. Naltrexone blocks the effects of ingested heroin; however, evidence is conflicting regarding the best delivery method. Objectives The primary purpose of the trial was to evaluate the clinical effectiveness and cost-effectiveness of extended-release naltrexone versus standard oral naltrexone versus relapse prevention therapy without medication for opioid use disorder (OUD). Design This was a 3-year, definitive, three-centre, three-arm, parallel group, placebo-controlled, double-blind, double-dummy, randomised controlled trial. Setting Two specialist NHS outpatient addiction clinics: one in London and one in Birmingham. Participants Planned study sample – 300 adult patients with OUD who had completed detoxification. Interventions One iGen/Atral-Cipan Extended Release Naltrexone device (iGen/Atral-Cipan, Castanheira do Ribatejo, Portugal) (765 mg naltrexone or placebo) at day 0 of study week 1. Three weekly directly observed active or placebo oral naltrexone tablets (2 × 50 mg, Monday and Wednesday; 3 × 50 mg, Friday) at day 0 of study week 1 (for 4 weeks) and then an 8-week regimen of patient-administered dosing at the same dosing level. Main outcome measure The primary outcome measure was the proportion of heroin-negative urine drug screen (UDS) results at the end of the 12-week post-randomisation time point. Results Six patients were recruited and randomised to receive study interventions. Two patients had no positive UDS samples for heroin during the 12-week treatment period, one patient had only one positive UDS sample and the remaining patients had two, six and eight positive UDS results for heroin. All patients had at least one missed clinic visit (range 1–14). Conclusions Considerable problems were encountered with (1) the stipulated requirement of a validated ‘detoxified’ status prior to the initiation of the study naltrexone, (2) the requirement for a consent cooling-off period and (3) delays awaiting the surgical implant procedure. Major upheaval to the organisation and delivery of NHS community treatment services across England led to extremely poor levels of actual entry of patients into the trial. Research-vital clinical and procedural requirements were, therefore, more challenging to implement. The potential therapeutic value of the opioid antagonist naltrexone still needs clear investigation, including comparison of the established oral form with the new ultra-long-acting depot implant formulations (for which no licensed products exist in Europe). Despite the small number of study participants, some tentative conclusions can be reached, relevant to potential future work. The blinding of the active/placebo medications appeared to be good. Self-report was not sufficient to detect instances of heroin use. Self-report plus UDS information provided a fuller picture. Instances of lapsed heroin use were not necessarily followed by full relapse, and future work should consider the lapse–relapse relationship. The prison release setting also warrants special consideration. In future, investigators should consider seeking ethics approval for studies in which clinical procedures to accelerate the treatment process are permitted, even if outside orthodox clinical practice, if they address a clinical need at the time of challenge and clinical risk. In addition, it may be appropriate to seek exemption from the ordinary requirement of a cooling-off period after securing consent because it is often essential to initiate treatment promptly. Trial registration Current Controlled Trials ISRCTN95809946. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 3. See the NIHR Journals Library website for further project information.

scholarly journals Buprenorphine therapy in the setting of induced opioid withdrawal from oral naltrexone: a case report

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Laura M. Szczesniak ◽  
Vincent J. Calleo ◽  
Ross W. Sullivan
Keyword(s):  
Emergency Department ◽  
Acute Treatment ◽  
Opioid Use Disorder ◽  
Opioid Withdrawal ◽  
Opioid Use ◽  
Accidental Ingestion ◽  
Heroin Use ◽  
Case Presentation ◽  
Acute Withdrawal ◽  
Oral Naltrexone

Abstract Background Patients with opioid use disorder (OUD) frequently present to the emergency department for acute treatment of overdose and withdrawal. Case presentation A 29-year-old male presented to the emergency room after intravenous heroin use followed by accidental ingestion of naltrexone. He was treated with buprenorphine with significant improvement in his Clinical Opioid Withdrawal Score, from moderately severe to mild withdrawal symptoms within a few hours. Conclusion Buprenorphine and minimal supportive care can be used to treat acute withdrawal precipitated by oral naltrexone in patients with OUD.

scholarly journals Levels of Impulsivity, Hyperactivity, and Inattention and the Association with Mental Health and Substance Use Severity in Opioid-Dependent Patients Seeking Treatment with Extended-Release Naltrexone

2021 ◽  
Vol 10 (19) ◽  
pp. 4558
Author(s):  
Ann Tarja Karlsson ◽  
John-Kåre Vederhus ◽  
Thomas Clausen ◽  
Bente Weimand ◽  
Kristin Klemmetsby Solli ◽  
...  
Keyword(s):  
Substance Use ◽  
Adult Adhd ◽  
Extended Release ◽  
Mental Distress ◽  
Opioid Use Disorder ◽  
Self Report ◽  
Opioid Antagonist ◽  
Opioid Use ◽  
History Of ◽  
Amphetamine Use

The level of impulsivity, hyperactivity, and inattention (IHI) is higher among patients with substance use disorder (SUD) than in the general population. However, the prevalence of such symptoms in patients seeking treatment with an opioid antagonist, such as extended-release naltrexone (XR-NTX), is unknown. We screened 162 patients with opioid use disorder (OUD) seeking treatment with XR-NTX in Norway using the Adult ADHD Self-Report Scale (ASRS) to estimate the prevalence of IHI alongside an assessment of mental and physical health and substance use. Sixty-six patients scored above the clinical cut-off on the ASRS. Higher levels of IHI were significantly associated with a longer history of frequent amphetamine use, current alcohol use, and greater mental distress. Mental distress was the strongest factor associated with higher levels of IHI. The introduction of screening for IHI and mental distress in opioid maintenance treatment and XR-NTX would likely improve the quality of care and enable clinicians to tailor interventions to the needs of patients with high levels of IHI to prevent treatment discontinuation.

scholarly journals Assessment of the impact of an opioid-specific education series on rates of medication-assisted treatment for opioid use disorder in veterans

2020 ◽  
Author(s):  
Taylor Kirby ◽  
Robert Connell ◽  
Travis Linneman
Keyword(s):  
Multivariate Analysis ◽  
Hospital Admission ◽  
Intervention Group ◽  
Opioid Use Disorder ◽  
Control Group ◽  
Opioid Use ◽  
Motivation To Change ◽  
Heroin Use ◽  
Ed Visits ◽  
The Impact

Abstract Purpose The impact of a focused inpatient educational intervention on rates of medication-assisted therapy (MAT) for veterans with opioid use disorder (OUD) was evaluated. Methods A retrospective cohort analysis compared rates of MAT, along with rates of OUD-related emergency department (ED) visits and/or hospital admission within 1 year, between veterans with a diagnosis of OUD who completed inpatient rehabilitation prior to implementation of a series of group sessions designed to engage intrinsic motivation to change behavior surrounding opioid abuse and provide education about MAT (the control group) and those who completed rehabilitation after implementation of the education program (the intervention group). A post hoc, multivariate analysis was performed to evaluate possible predictors of MAT use and ED and/or hospital readmission, including completion of the opioid series, gender, age (>45 years), race, and specific prior substance(s) of abuse. Results One hundred fifty-eight patients were included: 95 in the control group and 63 in the intervention group. Rates of MAT were 25% (24 of 95 veterans) and 75% (47 of 63 veterans) in control and intervention groups, respectively (P < 0.01). Gender, completion of the opioid series, prior heroin use, and marijuana use met prespecified significance criteria for inclusion in multivariate regression modeling of association with MAT utilization, with participation in the opioid series (odds ratio [OR], 9.56; 95% confidence interval [CI], 4.36-20.96) and prior heroin use (OR, 3.26; 95% CI, 1.18-9.01) found to be significant predictors of MAT utilization on multivariate analysis. Opioid series participation and MAT use were independently associated with decreased rates of OUD-related ED visits and/or hospital admission (hazard ratios of 0.16 [95% CI, 0.06-0.44] and 0.32 [95% CI, 0.14-0.77], respectively) within 1 year after rehabilitation completion. Conclusion Focused OUD-related education in a substance abuse program for veterans with OUD increased rates of MAT and was associated with a decrease in OUD-related ED visits and/or hospital admission within 1 year.

scholarly journals Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 “optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)”

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Matisyahu Shulman ◽  
Roger Weiss ◽  
John Rotrosen ◽  
Patricia Novo ◽  
Elizabeth Costello ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Extended Release ◽  
Primary Outcome ◽  
Opioid Use Disorder ◽  
Drug Abuse Treatment ◽  
Opioid Use ◽  
National Drug ◽  
Retention In Treatment ◽  
Abuse Treatment

AbstractOpioid use disorder continues to be a significant problem in the United States and worldwide. Three medications—methadone, buprenorphine, and extended-release injectable naltrexone,— are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study “Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy” (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries

2020 ◽  
pp. 1-8
Author(s):  
Konstantinos Zisis ◽  
Panagiota Naoum ◽  
Kostas Athanasakis
Keyword(s):  
Sensitivity Analysis ◽  
Content Analysis ◽  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evaluation Method ◽  
Outcome Measure ◽  
Health Technology ◽  
European Countries ◽  
Common Practices

Abstract Objective To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. Methods We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. Results A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure—for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. Conclusions The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.

scholarly journals The association between cannabis use and outcome in pharmacological treatment for opioid use disorder

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Tea Rosic ◽  
Raveena Kapoor ◽  
Balpreet Panesar ◽  
Leen Naji ◽  
Darren B. Chai ◽  
...  
Keyword(s):  
Side Effects ◽  
Pharmacological Treatment ◽  
Addiction Treatment ◽  
Age Of Onset ◽  
Opioid Use Disorder ◽  
Cannabis Use ◽  
Self Report ◽  
Opioid Use ◽  
Differential Outcomes ◽  
Urine Drug

Abstract Background With the ongoing opioid crisis and policy changes regarding legalization of cannabis occurring around the world, it is necessary to consider cannabis use in the context of opioid use disorder (OUD) and its treatment. We aimed to examine (1) past-month cannabis use in patients with OUD, (2) self-reported cannabis-related side effects and craving, and (3) the association between specific characteristics of cannabis use and opioid use during treatment in cannabis users. Methods Participants receiving pharmacological treatment for OUD (n = 2315) were recruited from community-based addiction treatment clinics in Ontario, Canada, and provided information on past-month cannabis use (self-report). Participants were followed for 3 months with routine urine drug screens in order to assess opioid use during treatment. We used logistic regression analysis to explore (1) the association between any cannabis use and opioid use during treatment, and (2) amongst cannabis-users, specific cannabis use characteristics associated with opioid use. Qualitative methods were used to examine responses to the question: “What effect does marijuana have on your treatment?”. Results Past-month cannabis use was reported by 51% of participants (n = 1178). Any cannabis use compared to non-use was not associated with opioid use (OR = 1.03, 95% CI 0.87–1.23, p = 0.703). Amongst cannabis users, nearly 70% reported daily use, and half reported experiencing cannabis-related side effects, with the most common side effects being slower thought process (26.2%) and lack of motivation (17.3%). For cannabis users, daily cannabis use was associated with lower odds of opioid use, when compared  with occasional use (OR = 0.61, 95% CI 0.47–0.79, p < 0.001) as was older age of onset of cannabis use (OR = 0.97, 95% CI 0.94, 0.99, p = 0.032), and reporting cannabis-related side effects (OR = 0.67, 95% CI 0.51, 0.85, p = 0.001). Altogether, 75% of cannabis users perceived no impact of cannabis on their OUD treatment. Conclusion Past-month cannabis use was not associated with more or less opioid use during treatment. For patients who use cannabis, we identified specific characteristics of cannabis use associated with differential outcomes. Further examination of characteristics and patterns of cannabis use is warranted and may inform more tailored assessments and treatment recommendations.

scholarly journals Beyond Antibiotics: A Practical Guide for the Infectious Disease Physician to Treat Opioid Use Disorder in the Setting of Associated Infectious Diseases

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Nikhil Seval ◽  
Ellen Eaton ◽  
Sandra A Springer
Keyword(s):  
Infectious Disease ◽  
Extended Release ◽  
Hospital Admissions ◽  
Opioid Use Disorder ◽  
Evidence Based ◽  
Opioid Use ◽  
Patient Centered ◽  
Infectious Disease Physician ◽  
Centered Care ◽  
Acute Injection

Abstract Infections are a common cause of hospitalization for patients with opioid use disorder (OUD), and hospital admissions are rising in the context of the worsening US opioid crisis. Infectious disease (ID) physicians are frequently the first point of medical contact for these patients. In this article, we discuss the integration of evidence-based management of OUD and patient-centered care of hospitalized persons with acute injection-related infections. We describe the following components of a comprehensive approach for OUD with inpatient ID consultations: (1) how to screen for OUD; (2) how to initiate the 3 US Food and Drug Administration-approved medications for OUD (buprenorphine, methadone, and extended-release naltrexone); (3) how to manage acute pain and opioid-related conditions; and (4) how to link and integrate ID and OUD treatment after hospital discharge. These strategies reduce unplanned discharges and increase completion of recommended antimicrobial regimens.

Psychoeducational Strategies During Outpatient Transition to Extended-Release Naltrexone for Patients With Opioid Use Disorder

2018 ◽  
Vol 25 (4) ◽  
pp. 272-279
Author(s):  
Abigail Zavod ◽  
Sarah C. Akerman ◽  
Martha M. Snow ◽  
Matt Tierney ◽  
Maria A. Sullivan
Keyword(s):  
Treatment Adherence ◽  
Extended Release ◽  
The United States ◽  
Opioid Use Disorder ◽  
Opioid Withdrawal ◽  
Opioid Use ◽  
Major Barrier ◽  
Supportive Interventions ◽  
Outpatient Utilization ◽  
Withdrawal Management

BACKGROUND: The United States is experiencing an opioid epidemic. Better approaches to encourage outpatient utilization of Food and Drug Administration–approved medications for the treatment of opioid use disorder, including extended-release naltrexone (XR-NTX), are needed. Withdrawal management before initiation of XR-NTX is challenging for clinicians and patients and represents a major barrier to treatment. AIMS: To review psychoeducational strategies that support patients during outpatient withdrawal management and transition to XR-NTX. METHOD: We reviewed the literature on psychoeducational strategies used during opioid withdrawal management and described the role that nurses can play in facilitating transition to XR-NTX in a Phase 3, placebo-controlled, outpatient trial comparing induction regimens. RESULTS: Supportive interventions include general psychoeducation on addiction, overcoming ambivalence, treatment adherence, anticipating XR-NTX induction, managing psychological and physiological aspects of opioid withdrawal, risks of opioid use, and sources of support during recovery. CONCLUSIONS: Psychoeducational strategies led by nurses can promote treatment adherence during withdrawal management and induction onto XR-NTX.

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