Approximately 1/3 of opioid addicts are women of child-bearing age. Pregnancy during opioid dependence presents a complex array of therapeutic challenges. Methadone is the only maintenance pharmacotherapy recommended for use in pregnant opioid-dependent women. Methadone offers many benefits relative to continued untreated heroin addiction or medical detoxification, but it also has medical complications. Compared to non-drug exposed infants, opioid exposed infants have longer and more costly neonatal hospitalizations and display neurophysical and behavioral disruption. It is estimated that 55 percent-94 percent of infants exposed to opioids in utero will show signs of opioid withdrawal. Buprenorphine offers the potential of providing benefits comparable to methadone with fewer medical problems. Buprenorphine is reported to produce only a mild abstinence syndrome following abrupt withdrawal. Its potential will be assessed in a randomized controlled clinical trial comparing methadone and buprenorphine in this special population. Results will be compared to opiate dependent controls who choose nonpharmacological treatment. This comprehensive interdisciplinary effort will be conducted in the Center for Addiction of Pregnancy. Subjects randomized to equivalent optimal doses of methadone (N=35) or buprenorphine (N=35) will be followed through pregnancy and compared to nonpharmacologically treated (N=35) subjects. Primary outcome measures are: neonatal abstinence symptoms and length (days) of hospital stay. Secondary fetal/neonatal outcome measures are: standard antenatal measures, NICU Network Neurobehavioral Scale, fetal growth ratio, total anti-withdrawal medication given, infant cry behavior and physical birth parameters. Secondary maternal outcome measures include: treatment retention, objective and subjective measures o drug use, global assessments, dose adequacy and safety data. Additionally, mother and infant pharmacokinetic data will be collected to aid in interpretation of outcomes. The study will provide critical clinical data comparing the neonatal abstinence syndrome and safety/efficacy of methadone and buprenorphine in the mother and infant pre- and postpartum using rigorous scientific methodology.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
1R01DA012220-01A1
Application #
2908512
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Montoya, Ivan
Project Start
1999-09-30
Project End
2003-08-31
Budget Start
1999-09-30
Budget End
2000-08-31
Support Year
1
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Himes, Sarah K; Goodwin, Robert S; Rock, Colleen M et al. (2012) Methadone and metabolites in hair of methadone-assisted pregnant women and their infants. Ther Drug Monit 34:337-44
de Castro, Ana; Jones, Hendree E; Johnson, Rolley E et al. (2011) Methadone, cocaine, opiates, and metabolite disposition in umbilical cord and correlations to maternal methadone dose and neonatal outcomes. Ther Drug Monit 33:443-52
Concheiro, Marta; Shakleya, Diaa M; Huestis, Marilyn A (2011) Simultaneous analysis of buprenorphine, methadone, cocaine, opiates and nicotine metabolites in sweat by liquid chromatography tandem mass spectrometry. Anal Bioanal Chem 400:69-78
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Concheiro, Marta; Jones, Hendreé E; Johnson, Rolley E et al. (2011) Preliminary buprenorphine sublingual tablet pharmacokinetic data in plasma, oral fluid, and sweat during treatment of opioid-dependent pregnant women. Ther Drug Monit 33:619-26
Concheiro, Marta; Jones, Hendreé E; Johnson, Rolley E et al. (2010) Umbilical cord monitoring of in utero drug exposure to buprenorphine and correlation with maternal dose and neonatal outcomes. J Anal Toxicol 34:498-505
Concheiro, Marta; Jones, Hendreé; Johnson, Rolley E et al. (2010) Confirmatory analysis of buprenorphine, norbuprenorphine, and glucuronide metabolites in plasma by LCMSMS. Application to umbilical cord plasma from buprenorphine-maintained pregnant women. J Chromatogr B Analyt Technol Biomed Life Sci 878:13-20
Brunet, Bertrand R; Barnes, Allan J; Choo, Robin E et al. (2010) Monitoring pregnant women's illicit opiate and cocaine use with sweat testing. Ther Drug Monit 32:40-9
Concheiro, Marta; Jones, Hendreé E; Johnson, Rolley E et al. (2010) Maternal buprenorphine dose, placenta buprenorphine, and metabolite concentrations and neonatal outcomes. Ther Drug Monit 32:206-15
Jones, Hendree E; O'Grady, Kevin; Dahne, Jennifer et al. (2009) Management of acute postpartum pain in patients maintained on methadone or buprenorphine during pregnancy. Am J Drug Alcohol Abuse 35:151-6

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