Results 71 to 80 of about 7,007,196 (291)

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science

Clinical Pharmacology &Therapeutics, EarlyView.
New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Ksenia Blinova, Kimberly Chiu, Anik Chaturbedi, Jahan Cooper, Tromondae K. Feaster, Paula L. Hyland, Lidiya Stavitskaya, Wendy W. Wu, Jeffry Florian, Rodney Rouse   +9 more
wiley   +1 more source

Alcohol Screening Among Opioid Agonist Patients in a Primary Care Clinic and an Opioid Treatment Program [PDF]

, 2015
Problem alcohol use is associated with adverse health and economic outcomes, especially among people in opioid agonist treatment. Screening, brief intervention and referral to treatment (SBIRT) are effective in reducing alcohol use; however, issues ...
Rieckman, Traci, Katharina Wiest (12594496), Wiest, Katharina, Jan Klimas (3546944), Raina Croff (8607051), Traci Rieckman (12593203), Klimas, Jan, McCarthy, Denis, Denis McCarthy (4354777), Croff, Raina, Muench, John, John Muench (3908557), et al., McCarty, Dennis   +13 more
core   +1 more source

First Occurrence of Fatal Intoxication Involving Methiodone (IC‐26) in Finland; a Medicolegal Autopsy Case Report

Drug Testing and Analysis, EarlyView.
ABSTRACT Methiodone (IC‐26) is a non‐fentanyl novel synthetic opioid which has recently been detected in drug seizures in Europe. There is still limited data about the drug in published toxicological case work, both in non‐fatal and fatal cases. We present a medicolegal autopsy case report on a fatal intoxication in an individual undergoing opioid ...
Lasse Pakanen, Raimo A. Ketola, Pirkko Kriikku   +2 more
wiley   +1 more source

Evaluating comparative effectiveness of psychosocial interventions for persons receiving opioid agonist therapy for opioid use disorder: protocol for a systematic review

BMJ Open, 2018
Introduction The opioid crisis has resulted in increasing rates of death caused by problematic opioid use. Current clinical guidelines recommend that individuals with persons with opioid use disorder (OUD) receive pharmacological (eg, opioid agonist ...
Brian Hutton, Beverley Shea, Kimberly Corace, David Moher, Danielle B Rice, Becky Skidmore, Kednapa Thavorn, Sheena Taha, Dianna Wolfe, Fatemeh Yazdi, Beth A Sproule, Melanie Willows, Patricia Poulin, Gary Garber, Amy Porath, Leila Esmaeilisaraji   +15 more
doaj   +1 more source

GLP‐1 Receptor Agonism Exacerbates Activity‐Based Anorexia in Mice

International Journal of Eating Disorders, EarlyView.
ABSTRACT Objective Glucagon‐like peptide‐1 receptor (GLP‐1R) agonists reduce food intake and body weight, suggesting they should be avoided in anorexia nervosa. However, preclinical evidence that these drugs reduce activity and reward‐seeking behavior raises the possibility that they might attenuate the compulsive‐like hyperactivity central to ABA ...
Amit Thakar, Travis E. Brown, Shane T. Hentges   +2 more
wiley   +1 more source

Nonclinical human neural new approach methodologies (NAMs): Electrophysiological assessment of opioid agonist and antagonist combination

NAM Journal
Background and Purpose: New approach methodologies (NAMs) including microphysiological systems in combination with human induced pluripotent stem cell (hiPSC)-derived neural cells and multielectrode array (MEA) have demonstrated utility for evaluating ...
Carlos Serna, III, Bhavya Bhardwaj, Tromondae K. Feaster, Ksenia Blinova   +3 more
doaj   +1 more source

The opioid crisis: past, present and future policy climate in Ontario, Canada

Substance Abuse Treatment, Prevention, and Policy, 2017
Background Addressing opioid use disorder has become a priority in Ontario, Canada, because of its high economic, social and health burden. There continues to be stigma and criticism relating to opioid use disorder and treatment options.
Kristen A. Morin, Joseph K. Eibl, Alexandra M. Franklyn, David C. Marsh   +3 more
doaj   +1 more source

Mechanisms of an Inhibitory Control Training to Reduce Binge Eating—The Randomized Controlled MIND BINGES Trial

International Journal of Eating Disorders, EarlyView.
ABSTRACT Objective Psychotherapy is the first‐line treatment for eating disorders (EDs), yet only about half of patients benefit long‐term. Bulimia nervosa (BN), Binge‐Eating‐Disorder (BED), and non‐underweight EDs with regular binge eating (> 2 binge‐eating episodes per month within the last 3 months) (OSFED/UFED) form a transdiagnostic group ...
Sebastian M. Max, Katrin E. Giel, Christian Plewnia, Simone Weller, Andreas J. Fallgatter, Veronika Lossa, Stephan Zipfel, Kathrin Schag   +7 more
wiley   +1 more source

Use of microdoses for induction of buprenorphine treatment with overlapping full opioid agonist use: the “Bernese method”

Substance Abuse and Rehabilitation, 2016
Robert Hämmig,1 Antje Kemter,2 Johannes Strasser,2 Ulrich von Bardeleben,1 Barbara Gugger,1 Marc Walter,2 Kenneth M Dürsteler,2 Marc Vogel2 1Division of Addiction, University Psychiatric Services Bern, Bern, Switzerland; 2Division of Substance ...
Hämmig R, Kemter A, Strasser J, von Bardeleben U, Gugger B, Walter M, Dürsteler KM, Vogel M   +7 more
doaj  

Progress report on new epilepsy treatments: A summary of the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices (EILAT XVIII). II. Treatments in more advanced clinical development

Epilepsia, EarlyView.
Abstract This article summarizes data for 13 investigational treatments for which at least preliminary seizure outcome data in patients with epilepsy were reported at the Eighteenth Eilat Conference on New Antiepileptic Drugs and Devices held in Madrid, Spain, on May 3–6, 2026.
Meir Bialer, Cecilie Johannessen Landmark, Matthias J. Koepp, Emilio Perucca, Piero Perucca, Torbjörn Tomson, H. Steve White, Elaine Wirrell   +7 more
wiley   +1 more source