Though clearly beneficial, the use of methadone during pregnancy remains controversial in part to the large percentage [of newborns having signs of cpioid withdrawal requiring 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 (JEUSOM) have directed this revised application and suggest that buprenorphine results in less neonatal abstinence syndrome (NAS) and improved birth outcomes relative to mettmdone. The proposed randomized, parallel group study will be the first multi-site trial to assess in opioid-dependent pregnant women the efficacy of buprenorphine for reducing NAS relative to methadone. JHUSOM is the Lead Site for this study involving five U.S. and two international sites. The Vienna team skilled in addiction medicine, psychiatry, pediatrics, obstetrics, neonatology, and controlled clinical trials will assure ;omprehensive oversight and rigorous scientific integrity of the study, Opioid-dependent pregnant women will be randomized to optimal doses of buprenorphine (n=26) or methadone (n=26) 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; physical birth parameter of head circtunference; 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. This first study will e_tablish an infrastructure and network with expertise in conducting controlled trials with pharmacotherapies for substance dependent 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 nnioid-denendent women,

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
3R01DA018417-04S1
Application #
7612971
Study Section
Special Emphasis Panel (ZDA1-KXN-G (28))
Program Officer
Oversby, Steven
Project Start
2004-09-30
Project End
2009-06-30
Budget Start
2007-07-01
Budget End
2008-06-30
Support Year
4
Fiscal Year
2008
Total Cost
$58,093
Indirect Cost
Name
Medical University of Vienna
Department
Type
DUNS #
300926289
City
Vienna
State
Country
Austria
Zip Code
1090
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Metz, Verena E; Comer, Sandra D; Wuerzl, Johanna et al. (2014) Characteristics and quality of life of opioid-dependent pregnant women in Austria. Arch Womens Ment Health 17:529-39
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
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
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
Winklbaur-Hausknost, Bernadette; Jagsch, Reinhold; Graf-Rohrmeister, Klaudia et al. (2013) Lessons learned from a comparison of evidence-based research in pregnant opioid-dependent women. Hum Psychopharmacol 28:15-24
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
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
Metz, Verena; Kochl, Birgit; Fischer, Gabriele (2012) Should pregnant women with substance use disorders be managed differently? Neuropsychiatry (London) 2:29-41

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