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Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

Pregnancy Clinical Trial

Official title:
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

Clinical Trial Summary

This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored.

Clinical Trial Description

Opioid use has reached a staggering level and the associated deaths, neonatal consequences and economic impact are devastating. Buprenorphine and methadone are the two most commonly used medications for pregnant women in a Medication Assisted Treatment (MAT) program. Yet, the target concentration of these agents is not clearly identified. Furthermore, the relationship between drug exposure and adverse effects such as Neonatal Abstinence Syndrome and neurodevelopmental outcomes is unclear but contemporary thinking is that exposure (defined by maternal dose) is unrelated to adverse outcomes. The benefit of an MAT strategy is based on strong clinical data that demonstrates an improvement in perinatal outcomes in women participating in an MAT program. However, some women prefer to stop opioid medications entirely , but are not afforded this option in many MAT programs. The possibility that MAT is associated with some harms has received little attention but there are data that suggest that opioids adversely affect the fetal brain. If MAT is indeed associated with potential harms, then the option of Medically Assisted Withdrawal could be considered. This study will define the plasma concentration of buprenorphine associated with maternal withdrawal . Additionally, the relationship between buprenorphine concentration in maternal and infant hair, placenta , meconium and cord and neonatal NAS markers will be assessed. That investigation will define exposure not by maternal dose but by the buprenorphine concentration in these matrices. Exposure will also be related to neurodevelopmental outcomes. Strategies for dose reduction or elimination will be assessed in a cohort of women who desire a reduction or elimination of their opioid exposure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03831113
Study type Interventional
Source University of Pittsburgh
Contact
Status Terminated
Phase Phase 2
Start date April 13, 2019
Completion date December 22, 2022
View Details
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