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pupillometry opioids

Ernest A Kopecky, Alison B Fleming, Naama Levy-Cooperman, Melinda O'Connor, Edward Sellers
Oxycodone DETERx(®) (Collegium Pharmaceutical Inc, Canton, MA) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate-release oxycodone. Subjects with a history of recreational opioid use who were nondependent/nontolerant to opioids were enrolled...
September 27, 2016: Journal of Clinical Pharmacology
Stephen C Harris, Alessandra Cipriano, Ram P Kapil, Naama Levy-Cooperman, Salvatore V Colucci, Pierre Geoffroy, Talar Hopyan
OBJECTIVES:  A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the oral abuse potential and pharmacokinetics (PK) of HYD intact, chewed, or milled to fine particles in comparison with hydrocodone solution or placebo. DESIGN:  Single-center, double-blind, randomized, five-period, five-treatment crossover study...
September 19, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Naama Levy-Cooperman, Gail McIntyre, Laura Bonifacio, Michael McDonnell, J Michael Davenport, Paul S Covington, Leonard S Dove, Edward M Sellers
Drugs with μ-opioid receptor (OR) activity can be associated with abuse and misuse. The peripherally acting mixed μ-OR and κ-OR agonist and δ-OR antagonist, eluxadoline, is approved in the US for the treatment of irritable bowel syndrome with diarrhea. In two separate crossover studies, we evaluated the oral and intranasal abuse potential of eluxadoline versus placebo and the active control oxycodone. Healthy recreational opioid users received eluxadoline 100, 300, and 1000 mg, oxycodone 30 and 60 mg, and placebo (oral study), or eluxadoline 100 and 200 mg, oxycodone 15 and 30 mg, and placebos matched to eluxadoline and oxycodone (intranasal study)...
September 19, 2016: Journal of Pharmacology and Experimental Therapeutics
Mona Darwish, Mary Bond, Yuju Ma, William Tracewell, Philmore Robertson, Lynn R Webster
OBJECTIVE: To compare the oral abuse potential of hydrocodone extended-release (ER) tablet developed with CIMA(®) Abuse-Deterrence Technology with that of hydrocodone immediate release (IR). DESIGN: Randomized, double-blind, placebo-controlled, crossover study. SETTING AND PATIENTS: One study site in the United States; adult nondependent, recreational opioid users. METHODS: After confirming their ability to tolerate and discriminate hydrocodone IR 45 mg from placebo, eligible participants were randomized to receive each of the following oral treatments once: finely crushed placebo, hydrocodone IR 45-mg powder, intact hydrocodone ER 45-mg tablet, and finely crushed hydrocodone ER 45-mg tablet...
June 21, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Víctor Mangas-Sanjuan, José Martín Pastor, Jens Rengelshausen, Roberta Bursi, Iñaki F Troconiz
AIM: The aim of the present study was to characterize the pharmacokinetic/pharmacodynamic (PK/PD) properties of the active components of axomadol and to quantify their contribution to observed the pupillometric and analgesic (measured through the cold pressor test) effects linking the PD engagement biomarker with clinical response. METHODS: Healthy subjects (n = 74) received either placebo or axomadol orally at doses ranging from 66 mg to 225 mg following multiple dosing regimens in two separate clinical trials...
July 2016: British Journal of Clinical Pharmacology
Lynn R Webster, Ernest A Kopecky, Michael D Smith, Alison B Fleming
OBJECTIVE:  Evaluate the human abuse potential (HAP) of an experimental, microsphere-in-capsule formulation of extended-release oxycodone (oxycodone DETERx®) (herein "DETERx"). DESIGN:  Randomized, double-blind, double-dummy, positive- and placebo-controlled, single-dose, four-phase, four-treatment, crossover study. SETTING:  Clinical research site. SUBJECTS:  There were 39 qualifying subjects (72% male, 85% white, mean age of 27 years) with 36 completing all four Double-blind Treatment Periods...
June 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Stephen C Harris, Alessandra Cipriano, Salvatore V Colucci, Ram P Kapil, Pierre Geoffroy, Talar Hopyan, Naama Levy-Cooperman
OBJECTIVES: A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER® [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the intranasal abuse potential and pharmacokinetics of HYD coarse and fine particles vs hydrocodone powder or placebo. DESIGN: Single-center, double-blind, positive- and placebo-controlled, randomized, four-treatment crossover study. SUBJECTS: Healthy adult, nondependent, recreational opioid users with a history of intranasal abuse...
May 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Terri L Morton, Krishna Devarakonda, Kenneth Kostenbader, Jeannie Montgomery, Thomas Barrett, Lynn Webster
OBJECTIVE: To correlate abuse-related pharmacodynamic measures and pharmacokinetic measures after administering immediate-release/extended-release and immediate-release oxycodone/acetaminophen fixed-dose combination analgesics DESIGN: Randomized, double-blind, active- and placebo-controlled, 7-way crossover study SETTING: Contract research organization SUBJECTS: Nondependent recreational users of prescription opioids. METHODS: Participants received single doses of intact immediate-release/extended-release and immediate-release oxycodone/acetaminophen 15/650 mg, intact immediate-release/extended-release and immediate-release oxycodone/acetaminophen 30/1,300 mg, crushed immediate-release/extended-release and immediate-release oxycodone/acetaminophen 30/1,300 mg, and placebo...
August 25, 2015: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Merlin D Larson, Matthias Behrends
Portable infrared pupillometers provide an objective measure of pupil size and pupillary reflexes, which for most clinicians was previously only a visual impression. But despite the fact that pupillometry can uncover aspects of how the human pupil reacts to drugs and noxious stimulation, the use of pupillometry has not gained widespread use among anesthesiologists and critical care physicians. The present review is an introduction to the physiology of pupillary reflexes and the currently established clinical applications of infrared pupillometry, which will hopefully encourage physicians to use this diagnostic tool in their clinical practice...
June 2015: Anesthesia and Analgesia
Annalisa Monaco, Ruggero Cattaneo, Luca Mesin, Eleonora Ortu, Mario Giannoni, Davide Pietropaoli
Using computerized pupillometry, our previous research established that the autonomic nervous system (ANS) is dysregulated in patients suffering from temporomandibular disorders (TMDs), suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD. However, pain modulation hypotheses for TMD are still lacking. The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior and pain through μ, κ, and δ opioid receptors. Transcutaneous electrical nerve stimulation (TENS) has been extensively used for pain relief, as low-frequency stimulation can activate µ receptors...
2015: PloS One
A Brokjaer, A E Olesen, L L Christrup, A Dahan, A M Drewes
BACKGROUND: Opioid antagonists are increasingly used to abolish the gastrointestinal side effects of opioids. However, they can potentially interfere with local analgesia exerted via opioid receptors in the gut. Thus, in the current study we aimed to explore the effect of rectal morphine before and after blocking opioid receptors outside the central nervous system with methylnaltrexone (MNTX). METHODS: In this randomized, placebo controlled, cross-over study 15 healthy male participants received the following drugs at three separate sessions: (i) placebo, (ii) 30 mg morphine administered per rectum, or (iii) 12 mg MNTX given subcutaneously before 30 mg rectal morphine...
May 2015: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
Linda M Rorick-Kehn, Jennifer W Witcher, Stephen L Lowe, Celedon R Gonzales, Mary Ann Weller, Robert L Bell, John C Hart, Anne B Need, Jamie H McKinzie, Michael A Statnick, Jeffrey G Suico, David L McKinzie, Sitra Tauscher-Wisniewski, Charles H Mitch, Randall R Stoltz, Conrad J Wong
BACKGROUND: Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression. The kappa opioid receptor antagonist, LY2456302, exhibits ~30-fold higher affinity for kappa opioid receptors over mu opioid receptors, which is the next closest identified pharmacology. METHODS: Here, we determined kappa opioid receptor pharmacological selectivity of LY2456302 by assessing mu opioid receptor antagonism using translational pupillometry in rats and humans...
2015: International Journal of Neuropsychopharmacology
Elliot Ehrich, Ryan Turncliff, Yangchun Du, Richard Leigh-Pemberton, Emilio Fernandez, Reese Jones, Maurizio Fava
Although opioids have known antidepressant activity, their use in major depressive disorder (MDD) has been greatly limited by risk of abuse and addiction. Our aim was to determine whether opioid modulation achieved through a combination of a μ-opioid partial agonist, buprenorphine (BUP), and a potent μ-opioid antagonist, samidorphan (SAM), would demonstrate antidepressant activity without addictive potential. A placebo-controlled crossover study assessed the opioid pharmacodynamic profile following escalating doses of SAM co-administered with BUP in opioid-experienced adults...
May 2015: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
Paul Glue, Michelle Lockhart, Fred Lam, Noelyn Hung, Cheung-Tak Hung, Lawrence Friedhoff
Noribogaine is the active metabolite of the naturally occurring psychoactive substance ibogaine, and may help suppress withdrawal symptoms in opioid-dependent subjects. The objectives of this Phase I study were to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of noribogaine. In this ascending single-dose, placebo-controlled, randomized, double-blind, parallel-group study in 36 healthy drug-free male volunteers, 4 cohorts (n = 9) received oral doses of 3, 10, 30, or 60 mg or matching placebo, with intensive safety and pharmacokinetic assessments out to 216 hours, along with pharmacodynamic assessments sensitive to the effects of mu-opioid agonists...
February 2015: Journal of Clinical Pharmacology
Mark A Connelly, Jacob T Brown, Gregory L Kearns, Rawni A Anderson, Shawn D St Peter, Kathleen A Neville
OBJECTIVE: Pupillometry has been used to assess pain intensity and response to analgesic medications in adults. The aim of this observational study was to explore proof of concept for the use of this technique in paediatric patients. Changes in pupil parameters before and after opioid exposure also were evaluated. DESIGN AND SETTING: This was a single-centre, prospective study conducted at an academic paediatric medical centre. PATIENTS: Children 9-17 years of age undergoing elective surgical correction of pectus excavatum were enrolled into a protocol approved by the human ethical committee (institutional review board)...
December 2014: Archives of Disease in Childhood
Mark D Rollins, John R Feiner, Jessica M Lee, Sameer Shah, Merlin Larson
BACKGROUND: The pupillary light reflex is a critical component of the neurologic examination, yet whether it is present, depressed, or absent is unknown in patients with significant opioid toxicity. Although opioids produce miosis by activating the pupillary sphincter muscle, these agents may induce significant hypercarbia and hypoxia, causing pupillary constriction to be overcome via sympathetic activation. The presence of either "pinpoint pupils" or sympathetically mediated pupillary dilation might prevent light reflex assessment...
November 2014: Anesthesiology
Beatrice Setnik, Marta Sokolowska, Franklin Johnson, John Oldenhof, Myroslava Romach
OBJECTIVE: This paper aimed to evaluate the effects of coadministered immediate-release morphine and ethanol on safety, pharmacokinetic, and pharmacodynamic measures. METHODS: In the first stage of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men with a history of moderate drinking received morphine 50 mg+ethanol 0.7 g/kg, morphine 50 mg+ethanol placebo, and morphine placebo+ethanol 0.7 g/kg. In the second stage, participants received either a lower (30 mg) or higher (80 mg) morphine dose (alone and in combination with ethanol) depending on their tolerability to treatments in stage 1...
May 2014: Human Psychopharmacology
Lynn R Webster, Robert L Rolleri, Glenn C Pixton, Kenneth W Sommerville
BACKGROUND: Abuse-deterrent formulations attempt to address public health and societal concerns regarding opioid abuse. Oxycodone HCl-niacin tablets combine oxycodone HCl with niacin and functional inactive excipients to create potential barriers to oral, intranasal, and intravenous abuse. This study compared the relative abuse potential of oral immediate-release oxycodone HCl-niacin with that of oral immediate-release oxycodone HCl and placebo in nondependent, recreational opioid users...
2012: Substance Abuse and Rehabilitation
Stephen C Harris, Peter J Perrino, Ira Smith, Megan J Shram, Salvatore V Colucci, Cynthia Bartlett, Edward M Sellers
The objective of this study was to evaluate abuse potential, pharmacokinetics, pharmacodynamics, and safety of intranasally administered, crushed reformulated OxyContin® (oxycodone HCl controlled-release) tablets (ORF), relative to crushed original OxyContin® (OC), oxycodone powder (Oxy API), and OC placebo. This randomized, double-blind, positive- and placebo-controlled crossover study enrolled healthy, adult, nonphysically dependent recreational opioid users with recent history of intranasal drug abuse (N = 27)...
April 2014: Journal of Clinical Pharmacology
Beatrice Setnik, Kenneth Sommerville, Veeraindar Goli, Ling Han, Lynn Webster
OBJECTIVES: To compare the pharmacodynamic effects, including self-reports of "drug liking" and "high," of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules (MSN), crushed morphine sulfate controlled-release (CR) tablets, and placebo in an abuse potential study. DESIGN: Randomized, double-blind, placebo-controlled, three-way crossover study. SETTING: Single-center. SUBJECTS: Nondependent recreational opioid users...
August 2013: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
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