N percentage of newborns having signs of opioid withdrawal requiting medical intervention and extended hospitalization.] Though clearly beneficial, the use of methadone during pregnancy remains controversial due in part to the large l 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 synd. """"""""-ae 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-sepcific 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
3R01DA018410-04S1
Application #
7612975
Study Section
Special Emphasis Panel (ZDA1-KXN-G (28))
Program Officer
Oversby, Steven
Project Start
2004-09-24
Project End
2009-06-30
Budget Start
2007-07-01
Budget End
2008-06-30
Support Year
4
Fiscal Year
2008
Total Cost
$21,178
Indirect Cost
Name
University of Vermont & St Agric College
Department
Psychiatry
Type
Schools of Medicine
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405
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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
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
McNicholas, Laura F; Holbrook, Amber M; O'Grady, Kevin E et al. (2012) Effect of hepatitis C virus status on liver enzymes in opioid-dependent pregnant women maintained on opioid-agonist medication. Addiction 107 Suppl 1:91-7
Benningfield, Margaret M; Dietrich, Mary S; Jones, Hendrée E et al. (2012) Opioid dependence during pregnancy: relationships of anxiety and depression symptoms to treatment outcomes. Addiction 107 Suppl 1:74-82
Baewert, Andjela; Jagsch, Reinhold; Winklbaur, Bernadette et al. (2012) Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics. Eur Addict Res 18:130-9
Jones, Hendrée E; Kaltenbach, Karol; Heil, Sarah H et al. (2012) Nonserious adverse events in randomized trials with opioid-dependent pregnant women: direct versus indirect measurement. Am J Addict 21 Suppl 1:S1-4

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