This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Though clearly beneficial, the use of methadone during pregnancy remains controversial due in part to the large percentage of newborns having signs of opioid 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 (JHUSOM) suggest that buprenorphine results in improved birth outcomes and fewer neonatal abstinence signs (NAS) relative to methadone. The current randomized, parallel group study is the first multi-site trial to assess the efficacy of buprenorphine for reducing NAS relative to methadone in opioid-dependent pregnant women. The University of Vermont (UVM) site will participate in the multi-site trial lead by JHUSOM along with four other U.S. and two international sites. To do so, we have brought together a multidisciplinary team trained in psychiatry, addiction medicine, obstetrics, neonatology and research methodology with the professional expertise to provide comprehensive care for the participants and rigorous scientific expertise to conduct the study. Opioid-dependent pregnant women at the UVM site will be admitted to our General Clinical Research Center (GCRC) for approximately three days to be screened for eligibility. Those eligible to participate will be randomized to receive either methadone (n=24) or buprenorphine (n=24). Induction onto double-blind, double-dummy study medications will also occur as inpatient admissions to the GCRC for approximately another three days to provide rigorous scientific control and maximize participant safety. For the remainder of the study, medication administration and other treatment services will occur at our outpatient treatment clinic. Participants will be followed throughout pregnancy and 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;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. The UVM site has unique expertise, experience, facilities and resources, including the GCRC, to contribute to this new potential network designed to conduct clinical trials in a difficult to recruit population (i.e., drug-abusing 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 opioid-dependent women.
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