Though clearly beneficial, the use of methadone during pregnancy remains controversial partly due to the large percentage of newborns having signs of opioid withdrawal requiring medical intervention and extended hospitalization. A newly approved medication, Buprenorphine, 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 use results in improved birth outcomes and less neonatal abstinence syndrome (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. The Wayne State University (WSU) Site proposes to participate in the multi-site trial lead by JHUSOM involving six U.S. and two international sites. The Substance Abuse Research division (SARD) at WSU has brought together a multi-disciplinary group trained in addiction medicine, psychiatry, pediatrics, obstetrics, neonatology, and controlled clinical trials with the professional expertise to provide comprehensive care for the subjects and rigorous scientific integrity for the study. At this site subjects randomized to equivalent optimal doses of methadone (n=20) or buprenorphine (n=20) will be followed through 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 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 this site, a pilot study will be conducted in which maternal salivary cortisol levels during pregnancy and labor and neonatal stressed (after heel prick blood draw) and unstressed salivary cortisol levels will be obtained. In addition, the WSU site also proposes to extend neonatal follow up to 6 months. The WSU site has unique expertise and experience (including participation in the NIDA Clinical Trial Network) and resources to contribute to this new potential network designed to conduct pharmacotherapy trials for substance abusing and dependent individuals in a difficult to recruit population (i.e., pregnant women). The Wayne State site also proposes to participate in the NICU (Neonatal Intensive Care Unit) Network Neurobehavioral Scale (NNNS) as a secondary outcome measure in collaboration with the Providence, Rhode Island site and the lead site (Johns Hopkins).

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA015832-02
Application #
6952784
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
2005-07-01
Budget End
2006-06-30
Support Year
2
Fiscal Year
2005
Total Cost
$448,424
Indirect Cost
Name
Wayne State University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
001962224
City
Detroit
State
MI
Country
United States
Zip Code
48202
Kaltenbach, Karol; O'Grady, Kevin E; Heil, Sarah H et al. (2018) Prenatal exposure to methadone or buprenorphine: Early childhood developmental outcomes. Drug Alcohol Depend 185:40-49
Jones, Hendrée E; Seashore, Carl; Johnson, Elisabeth et al. (2016) Measurement of neonatal abstinence syndrome: Evaluation of short forms. J Opioid Manag 12:19-23
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
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

Showing the most recent 10 out of 26 publications