Buprenorphine Assignment in Pregnancy: Objective Criteria

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 DESCRIPTION (provided by applicant): Dr. Elizabeth E. Krans is an Assistant Professor of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh. Her long-term career goal is to become an independent investigator focused on optimizing the effectiveness of drug treatment during pregnancy to improve maternal and neonatal outcomes. The goal of this three-year K23 award is to provide Dr. Krans with the mentorship, time and support necessary to achieve the following training goals: a) develop a critical, substantive understanding of addiction medicine and the drug treatment process, b) develop the methodological skills necessary to evaluate and compare treatment interventions for pregnant women with substance use disorders and c) develop the practical skills in scientific management and leadership necessary to become an independent investigator. Methadone and buprenorphine are two clinically appropriate treatments in pregnancy. However, we do not know which treatment (methadone vs. buprenorphine) is most effective for a particular patient during pregnancy. In clinical settings, methadone and buprenorphine treatment programs have starkly different structures, procedures and ancillary services and the impact of these differences on maternal outcomes has not been evaluated. To achieve this goal, Dr. Krans will conduct a pilot randomized clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependent pregnant women. The primary research aims are to 1) evaluate the feasibility of conducting a randomized study comparing office-based buprenorphine vs. federally licensed methadone programs; 2) describe the perspectives of pregnant women and their providers regarding buprenorphine vs. methadone for the treatment of opioid dependence during pregnancy; 3) assess the feasibility of evaluating treatment outcomes in the postpartum period and identify key postpartum functional outcomes relevant to reductions in illicit drug use during pregnancy. This study will identify the challenge specific to conducting research with this high-risk, highly transient population as well as develop and vet the outcome measures, assessment tools and participant tracking techniques needed to address problems related to poor recruitment and enrollment, early termination and difficulty with tracking and follow-up. Findings from this project will provide the preliminary data to suppor a R01 proposal for a comparative effectiveness clinical trial designed to compare office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependence during pregnancy. The ultimate goal of this line of research is develop clinical guidelines that can guide provider decision-making regarding the most effective treatment (buprenorphine vs. methadone) for opioid dependent pregnant women.