? CLINICAL PROJECT Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics This study proposes to address a pressing need in Obstetric Pharmacology related to buprenorphine treatment of opioid-addicted women. Pregnancy commonly motivates these women to stop use of `?street drugs? such as heroin so they seek assistance by coming to drug centers and being converted to either methadone or buprenorphine. These medications are also addicting but pregnancy outcomes are better with use of these medications than with use of street heroin or other opioid substances. The health care system commonly fails these women as the transition to methadone and buprenorphine is difficult, demeaning and at times does not satisfy their cravings. The failure rate with buprenorphine is 20% with most failures occurring during this transition period. Minimal data exists on dosing of buprenorphine in pregnancy and this may explain the high initial failure rate. This proposal will determine the pharmacokinetics of buprenorphine and determine if there is a better way to gauge dosing based on objective and physiological parameters of satiety. We will also determine which maternal, placental or fetal factors impact the risk of Neonatal Abstinence Syndrome.

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? CLINICAL PROJECT Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics This proposal focuses on expanding understanding of buprenorphine pharmacology and to determine a scientifically based dosing regimen for this medication to reduce the risk of maternal relapse and Neonatal Abstinence Syndrome.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Specialized Center--Cooperative Agreements (U54)
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Special Emphasis Panel (ZHD1)
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Magee-Women's Research Institute and Foundation
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Lemon, Lara S; Caritis, Steve N; Venkataramanan, Raman et al. (2018) Methadone Versus Buprenorphine for Opioid Use Dependence and Risk of Neonatal Abstinence Syndrome. Epidemiology 29:261-268
Caritis, Steve N; Hankins, Gary; Hebert, Mary et al. (2018) Impact of Pregnancy History and 17-Hydroxyprogesterone Caproate on Cervical Cytokines and Matrix Metalloproteinases. Am J Perinatol 35:470-480
Lemon, Lara S; Naimi, Ashley; Caritis, Steve N et al. (2018) The Role of Preterm Birth in the Association Between Opioid Maintenance Therapy and Neonatal Abstinence Syndrome. Paediatr Perinat Epidemiol 32:213-222
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Bastian, Jaime R; Chen, Huijun; Zhang, Hongfei et al. (2017) Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. Am J Obstet Gynecol 216:64.e1-64.e7
Kalluri, Hari V; Zhang, Hongfei; Caritis, Steve N et al. (2017) A physiologically based pharmacokinetic modelling approach to predict buprenorphine pharmacokinetics following intravenous and sublingual administration. Br J Clin Pharmacol 83:2458-2473
Caritis, Steve N; Bastian, Jaime R; Zhang, Hongfei et al. (2017) An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy. Am J Obstet Gynecol 217:459.e1-459.e6
Bustos, Martha; Venkataramanan, Raman; Caritis, Steve (2017) Nausea and vomiting of pregnancy - What's new? Auton Neurosci 202:62-72
Shaik, Imam H; Bastian, Jaime R; Zhao, Yang et al. (2016) Route of administration and formulation dependent pharmacokinetics of 17-hydroxyprogesterone caproate in rats. Xenobiotica 46:169-74
Lemon, Lara S; Zhang, Hongfei; Hebert, Mary F et al. (2016) Ondansetron Exposure Changes in a Pregnant Woman. Pharmacotherapy 36:e139-41

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