Articles: narcotic-antagonists.
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Randomized Controlled Trial Multicenter Study
Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients With Cancer.
Purpose This randomized, double-blind, multicenter study aimed to determine the dose of naldemedine, a peripherally-acting μ-opioid receptor antagonist, for future trials by comparing the efficacy and safety of three doses of naldemedine versus placebo in patients with cancer and opioid-induced constipation. Methods Patients ≥ 18 years old with cancer, an Eastern Cooperative Oncology Group performance status ≤ 2, who had been receiving a stable regimen of opioid analgesics for ≥ 2 weeks, had at least one constipation symptom despite laxative use, and no more than five spontaneous bowel movements (SBMs) during the past 14 days, were randomly assigned (1:1:1:1) to oral, once-daily naldemedine 0.1, 0.2, or 0.4 mg, or placebo, for 14 days. The primary end point was change in SBM frequency per week from baseline during the treatment period. ⋯ Treatment-emergent adverse events were more common with naldemedine (0.1 mg: 66.1%; 0.2 mg: 67.2%; 0.4 mg: 78.6%) than placebo (51.8%); the most common treatment-emergent adverse event was diarrhea. Conclusion Fourteen-day treatment with naldemedine significantly improved opioid-induced constipation in patients with cancer and was generally well tolerated. Naldemedine 0.2 mg was selected for phase III studies.
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Pharmacoepidemiol Drug Saf · Jun 2017
Low-dose naltrexone and opioid consumption: a drug utilization cohort study based on data from the Norwegian prescription database.
Low-dose naltrexone (LDN) is used in a wide range of conditions, including chronic pain and fibromyalgia. Because of the opioid antagonism of naltrexone, LDN users are probably often warned against concomitant use with opioids. In this study, based on data from the Norwegian prescription database, we examine changes in opioid consumption after starting LDN therapy. ⋯ Possibly, LDN users avoided opioids because of warnings on concomitant use or the patients continuing on LDN were less opioid dependent than those terminating LDN. Therapeutic effects of LDN contributing to lower opioid consumption cannot be ruled out. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.
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Administration of naloxone is a common treatment for opioid-dependent patients who present with respiratory depression. Although safe in opioid-naive patients, naloxone may cause severe and even life-threatening complications in opioid-dependent patients, including acute respiratory distress syndrome and myocardial infarction. ⋯ We present a 20-year-old morphine-addicted man who presented with methadone-induced respiratory depression and responded safely and effectively to intravenous administration of buprenorphine. Buprenorphine may be a useful alternative opioid reversal agent for opioid-dependent patients.
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Curr Psychiatry Rep · Jun 2017
ReviewUpdate on Barriers to Pharmacotherapy for Opioid Use Disorders.
The recent heroin and prescription opioid misuse epidemic has led to a sharp increase in the number of opioid overdose deaths in the USA. Notwithstanding the availability of three FDA-approved medications (methadone, buprenorphine, and naltrexone) to treat opioid use disorder, these medications are underutilized. This paper provides an update from the recent peer-reviewed literature on barriers to the use of these medications. ⋯ These barriers are interrelated and can be categorized as financial, regulatory, geographic, attitudinal, and logistic. While financial barriers are common to all three medications, other barriers are medication-specific. The adverse impact of the current opioid epidemic on public health can be reduced by increasing access to effective pharmacotherapy for opioid use disorder.