Though clearly beneficial, the use of methadone during pregnancy remains controversial in part to the large percentage of newborns having signs of opioid withdrawal requiring medical intervention and extended hospitalization. Buprenorphine, a newly approved medication for the treatment of non-pregnant opioid dependent patients, 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) have informed directly this revised application and suggest that buprenorphine 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 in opioid-dependent pregnant women the efficacy of buprenorphine for reducing NAS relative to methadone. Thomas Jefferson University (TJU) proposes to participate in the multi-site trial lead by JHUSOM involving six United States and two international sites. Maternal Addiction Treatment Education and Research (MATER) at TJU has brought together a multi-disciplinary team 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 of the study. Opioid-dependent pregnant women will be randomized to optimal doses of methadone (n=30) or buprenorphine (n=30) 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 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. 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. This study is part of a John Hopkins University School of Medicine amended application.
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