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Background and Objectives: Treatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient‐centered approach. To better support patient autonomy in the decision‐making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended‐release naltrexone (XR‐NTX). Methods: The posthoc analysis included adults with OUD currently receiving BUP (≤8 mg/day) and seeking transition to XR‐NTX (N = 101) in a residential setting. Baseline participant characteristics and OUD treatment history were reviewed. All patients completed a screening questionnaire that asked about their reasons for seeking transition to XR‐NTX and for choosing BUP. Results: The most common reasons for initiating a transition to XR‐NTX were "Seeking to be opioid‐free" (63.4%) and "Tired of daily pill taking" (25.7%). Positive predictors of transition included a more extensive BUP treatment history and a history of prescription opioid abuse. Most participants stated they were not aware of XR‐NTX as a treatment option when initiating BUP (78.2%). Discussions and Conclusions: Patients' reasons for seeking XR‐NTX transition, more extensive BUP treatment history, and a history of prescription opioid abuse, may positively predict outcomes. Scientific Significance: These findings may assist clinicians in optimizing outcomes of the BUP to XR‐NTX transition and supporting patients to make better informed MOUD decisions. [ABSTRACT FROM AUTHOR]

Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience. To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine. We performed a post hoc, cross-study comparison of the temporal pattern of opioid withdrawal during 1-week induction onto extended-release naltrexone by similar protocols enrolling two participant populations: participants with OUD entering a study with untreated opioid use (N = 378, NCT02537574) or on stable buprenorphine (BUP) treatment (N = 101, NCT02696434). The temporal pattern of withdrawal from induction day 1 through day 7 differed between the two participant populations for Clinical Opiate Withdrawal Score (COWS) and Subjective Opiate Withdrawal Score (SOWS): participants with untreated OUD prior to study entry were more likely to experience an earlier relative peak in opioid withdrawal followed by a gradual decline, whereas participants on stable BUP treatment prior to study entry were more likely to experience a relatively later, though still mild, peak opioid withdrawal. The peak COWS was reached at a mean (standard deviation) of 1.9 (1.5) days for participants with untreated OUD and 5.0 (1.5) days for participants on stable BUP. Daily peak cravings were generally higher for participants with untreated OUD than participants on stable BUP. Awareness of population-specific variations in the patient experience of opioid withdrawal may help clinicians anticipate the expected course of withdrawal. [ABSTRACT FROM AUTHOR]

Background and Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extended-release naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study.Methods: In a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51). Both groups received standing ancillary medications and psychoeducational counseling. Following negative naloxone challenge, participants received XR-NTX (day 8). The primary endpoint was the proportion of participants who received and tolerated XR-NTX.Results: There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407). The mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 during the treatment period (days 1-7) was similar for NTX/BUP and PBO-N/BUP groups (5.8 vs 6.3; P = .511). Opioid withdrawal symptoms during XR-NTX induction and post-XR-NTX observation period (days 8-11) were mild and similar between groups (mean peak COWS score: NTX/BUP, 5.1 vs PBO-N/BUP, 5.4; P = .464). Adverse events were mostly mild/moderate.Conclusions and Scientific Significance: Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX. (Am J Addict 2020;00:00-00). [ABSTRACT FROM AUTHOR]

Background and aims: Extended‐release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post‐hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo‐controlled trial of extended‐release injection naltrexone (XR‐NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness. Design This was a 24‐week multiple‐site, double‐blind, randomized trial of monthly XR‐NTX versus placebo injections. We analyzed time to dropout from treatment using survival analysis with an extended Cox model as a function of treatment (XR‐NTX versus placebo) and with weekly urine drug test (UDT) results for opioids at each week as a time‐dependent covariate. Setting: Thirteen addiction treatment programs in Russia, 2008–09. Participants: A total of 250 adults with opioid use disorder who had completed in‐patient detoxification. Intervention: XR‐NTX injection or placebo injection every 4 weeks with weekly clinic visits and biweekly counseling. Measurements Urine toxicology for opioids measured weekly and week of dropout from treatment. Findings The Cox model yielded a significant interaction of time‐dependent urine toxicology by treatment (P = 0.024). Among patients receiving placebo, a positive UDT in a given week increased the risk for dropout from treatment in the subsequent week [hazard ratio (HR) = 6.25; 95% confidence interval (CI) = 3.6–10.0], whereas among patients receiving XR‐NTX, a positive UDT result showed no significant effect on risk for dropout (HR = 1.67; 95% CI = 0.6–4.5). The proportion of patients who completed all 24 weeks without any positive UDT result was 31% on XR‐NTX compared with 20% on placebo (P = 0.051). Conclusions: Extended‐release injection naltrexone was effective at reducing the risk of dropout from opioid use disorder treatment after an episode of opioid use. Just under a third of patients (31%) on XR‐NTX had no opioid‐positive urine tests across the trial, but the hypothesis that this would differ from placebo (20%) was not confirmed. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Extended‐release naltrexone (XR‐NTX), a μ‐opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine–naloxone. We report outcomes for XR‐NTX in Vivitrol's Cost and Treatment Outcomes Registry. Design: Observational, open‐label, single‐arm, multi‐center registry assessing baseline characteristics and clinical and health‐related quality‐of‐life outcomes associated with XR‐NTX treatment in clinical practice. Setting: 32 US treatment centers from 2011 to 2013. Participants: Patients with opioid dependence who were prescribed XR‐NTX treatment and then enrolled into the registry. Measurements: Monthly visits were evaluated for the full population and for patient ubgroups retrospectively, defined by injection number, focusing on the period between baseline and month 6 (1‐, 2/3‐ or 6‐XR‐NTX). Findings: Of 403 enrolled patients, 395 were analyzed. Most patients (n = 349) received out‐patient care. On average, patients received five injections (median = 3; range = 1–25). The median number of injections administered within 6 months was higher in patients who at baseline were employed (three versus two unemployed, P = 0.02) or had private insurance (five versus two self‐payment, P = 0.005; versus two state‐funded, P < 0.001). The 1‐, 2/3‐ and 6‐XR‐NTX groups had 132, 152 and 111 patients, respectively. At baseline, the 6‐XR‐NTX patients were more likely to meet normal/minimal mental illness criteria and attend school and less likely to report recent drug use. Within 6 months, the 6‐XR‐NTX group demonstrated improvements in employment, mental health and psychosocial functioning, and decreases in opioid craving, drug use and drug‐related behavior. Conclusions: Among opioid‐dependent people receiving XR‐NTX treatment, better mental health, higher education and lower recent drug use at baseline are associated with greater treatment duration; in turn, longer treatment duration is associated with lower relapse rates and improved outcomes generally. [ABSTRACT FROM AUTHOR]

Perinatal opioid use disorders negatively impact maternal and neonatal outcomes and are a public health problem of increasing severity. More than half of women with a substance use disorder have a history of posttraumatic stress disorder that, if not adequately addressed, can impede substance use disorder treatment. This case report describes complexities in the treatment of a pregnant woman with opioid use disorder and posttraumatic stress disorder and reviews the psychotherapeutic and pharmacologic approaches available to treat these co-occurring disorders in pregnancy. This case demonstrates the importance of early screening and intervention for co-occurring posttraumatic stress disorder in pregnant women who use substances in a closely coordinated, multidisciplinary approach to improve outcomes for women and their infants. [ABSTRACT FROM AUTHOR]

Postsacrectomy hernias are uncommon and can present with different signs and symptoms, including constipation, fecal incontinence, bowel obstruction, pain, and posterior bulging. We report a 50-year-old man who underwent sacrectomy for malignant fibrosarcoma complicated with sacral hernia. He presented with obstructive symptoms resulting from a structured segment of herniated sigmoid colon and underwent bowel resection along with repair of his hernia. We additionally present a review of the literature and treatment of this rare disease. [ABSTRACT FROM AUTHOR]

In the past decade opioid pain reliever misuse among the U.S. population has increased to epidemic proportions. While the U.S. has only 4% of the world's population, Americans consume 86% of the world's opioids. In 2011, approximately 13 million people (5% of the U.S. population) reported nonmedical use of prescription opioids, which are now the second most commonly abused class of drug behind cannabis. There has been little in the way of formal study examining the association between mental illness and prescription opiate abuse, but preliminary evidence suggests a strong association. Neurobiological processes involved in psychosis and opiate abuse may partially explain this association. Despite compelling evidence of the growth in opiate misuse and the potential relationship with mental illness, patients with mental disorders and/or substance abuse are routinely excluded from randomized trials, making it impossible to better understand these phenomena. Treatment guidelines, especially regarding opioid agonists such as methadone and buprenorphine for people with mental illness, are woefully inadequate. We present the case of a young man with schizoaffective disorder who sustained an injury and developed chronic back pain. Opioids were prescribed and he quickly progressed to abusing increasing doses of opioids, which eventually led to daily heroin use. The young man struggled with repeated relapses, serious use-related consequences and suicide attempts. This case highlights the role of chronic pain and opioid prescribing, the segue from prescribed use to abuse and dependence, and the transition to heroin use. It demonstrates the difficulty patients may have in obtaining adequate treatment for co-occurring mental illness and substance abuse and how outcomes are improved when treatment is integrated to address both disorders. Comprehensive treatment must involve a combination of case management and medical management, including possible opioid replacement therapy.