Despite clear benefits, the use of methadone during pregnancy is controversial partly due to a high incidence of neonatal abstinence syndrome (NAS) 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 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. St. Joseph's Health Centre (SJHC) proposes to participate in the multi-site trial lead by JHUSOM involving six U.S. and two international sites. SJHC has brought together a multi-disciplinary group trained in addiction medicine, psychiatry, toxicology, 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=15) or buprenorphine (n=15) 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, is the extended follow-up of both neonates and mothers for 6 months. This study will provide pivotal data on the optimal management of pregnant opioid dependent women and establish a network for future studies with this population.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA015741-04
Application #
7255487
Study Section
Special Emphasis Panel (ZDA1-KXN-G (28))
Program Officer
Oversby, Steven
Project Start
2004-09-30
Project End
2010-06-30
Budget Start
2008-07-01
Budget End
2010-06-30
Support Year
4
Fiscal Year
2008
Total Cost
$200,710
Indirect Cost
Name
St. Joseph's Health Centre
Department
Type
DUNS #
206082448
City
Toronto
State
ON
Country
Canada
Zip Code
M6 1-B5
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
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
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
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
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
Kaltenbach, Karol; Holbrook, Amber M; Coyle, Mara G et al. (2012) Predicting treatment for neonatal abstinence syndrome in infants born to women maintained on opioid agonist medication. Addiction 107 Suppl 1:45-52

Showing the most recent 10 out of 28 publications