Though clearly beneficial, the use of methadone during pregnancy remains controversial due in part to the large l N percentage of newborns having signs of opioid withdrawal requiting medical intervention and extended hospitalization. A new medication, Buprenorphine, is approved by the Food and Drug Administration (FDA) for the treatment of non-pregnant opioid-dependent patients and produces only a mild abstinence syndrome following abrupt withdrawal.] Promising preliminary data from a double-blind randomized trial at the Johns Hopkins School of Medicine (JHUSOM) suggest that buprenorphine results in improved birth outcomes and fewer neonatal abstinence signs (NAS) relative to methadone. The current randomized, parallel group study will be the first multi-site trial to assess the efficacy of buprenorphine for reducing NAS relative to methadone in opioid-dependent pregnant women. The University of Vermont (UVM) site proposes to participate in the multi-site trial lead by JHUSOM involving four other U.S. and two international sites. To do so, we have brought together a multidisciplinary team trained in psychiatry, addiction medicine, obstetrics, and neonatology with the professional expertise to provide comprehensive care for the participants and rigorous scientific expertise for the study. At the UVM site, opioid-dependent pregnant women will be randomized to optimal doses of methadone (n=24) or buprenorphine (n=24) and followed throughout pregnancy. Treatment groups will be compared on the primary outcome measures of peak total NAS score; number of neonates treated for NAS; total amount of anti-withdrawal medication given to neonates treated for NAS; head circumference; and neonatal length of hospital stay. Secondary neonatal/fetal outcome measures include other physical, behavioral and safety parameters. Secondary maternal outcomes include treatment retention, drug use, medication safety, psychosocial functioning and dose adequacy. Unique to the UVM site, delay discounting will be compared between study participants and gestational age matched community volunteers. The results of this site-specific study have the potential to provide important insights into why some pregnant women abuse opiates despite the potential harm that may do to the fetus. The UVM site has unique expertise, experience and resources to contribute to this new potential network designed to conduct clinical trials in a difficult to recruit population (i.e., drug-abusing pregnant women). Overall, this study will provide pivotal data to the FDA to support an indication for the use of buprenorphine during pregnancy and potentially optimize strategies for safe and effective treatment of pregnant opioid-dependent women.
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| Jones, Hendrée E; Dengler, Erin; Garrison, Anna et al. (2014) Neonatal outcomes and their relationship to maternal buprenorphine dose during pregnancy. Drug Alcohol Depend 134:414-417 |
| Chisolm, Margaret S; Fitzsimons, Heather; Leoutsakos, Jeannie-Marie S et al. (2013) A comparison of cigarette smoking profiles in opioid-dependent pregnant patients receiving methadone or buprenorphine. Nicotine Tob Res 15:1297-304 |
| Jones, Hendrée E; Heil, Sarah H; Tuten, Michelle et al. (2013) Cigarette smoking in opioid-dependent pregnant women: neonatal and maternal outcomes. Drug Alcohol Depend 131:271-7 |
| Holbrook, Amber M; Jones, Hendree E; Heil, Sarah H et al. (2013) Induction of pregnant women onto opioid-agonist maintenance medication: an analysis of withdrawal symptoms and study retention. Drug Alcohol Depend 132:329-34 |
| Jones, Hendrée E; Heil, Sarah H; Baewert, Andjela et al. (2012) Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction 107 Suppl 1:5-27 |
| Salisbury, Amy L; Coyle, Mara G; O'Grady, Kevin E et al. (2012) Fetal assessment before and after dosing with buprenorphine or methadone. Addiction 107 Suppl 1:36-44 |
| Holbrook, Amber M; Baxter, Jason K; Jones, Hendrée E et al. (2012) Infections and obstetric outcomes in opioid-dependent pregnant women maintained on methadone or buprenorphine. Addiction 107 Suppl 1:83-90 |
| Meyer, Marjorie; Benvenuto, Anna; Howard, Diantha et al. (2012) Development of a substance abuse program for opioid-dependent nonurban pregnant women improves outcome. J Addict Med 6:124-30 |
| Coyle, Mara G; Salisbury, Amy L; Lester, Barry M et al. (2012) Neonatal neurobehavior effects following buprenorphine versus methadone exposure. Addiction 107 Suppl 1:63-73 |
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