Randomized controlled trials in pregnancy: Scientific and ethical aspects. Exposure to different opioid medications during pregnancy in an intra-individual comparison

Autor(en)

Annemarie Unger, Reinhold Jagsch, Hendree Jones, Amelia Arria, Harald Leitich, Klaudia Rohrmeister, Constantin Aschauer, Bernadette Winklbaur, Andjela Baewert, Gabriele Fischer

Abstrakt

Background Chronic medical conditions such as opioid dependence require evidence-based treatment recommendations.

However, pregnant women are under-represented in clinical trials. We describe the first within-subject comparison

of maternal and neonatal outcomes for methadone- versus buprenorphine-exposed pregnancies. Although

methadone is the established treatment of pregnant opioid-dependent women, recent investigations have shown a

trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of

maintenance medication that determines the occurrence of NAS; other factors such as maternal metabolism, illicit

substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors

in the assessment of randomized clinical trials. Case series description Three women who were part of the European

cohort of a randomized, double-blind multi-center trial with a contingency management tool [the Maternal Opioid

Treatment: Human Experimental Research (MOTHER) study], each had two consecutive pregnancies and were maintained

on either methadone or buprenorphine for their first and then the respective opposite, still-blinded medication

for their second pregnancy. Birth measurements, the total neonatal abstinence score, the total amounts of medication

used to treat NAS and the days of NAS treatment durationwere assessed. Results Both medicationswere effective and

safe in reducing illicit opioid relapse and avoiding preterm labor. Methadone maintenance yielded to a significantly

higher neonatal birth weight. Data patterns suggest that buprenorphine exposure was associated with lower neonatal

abstinence syndrome (NAS) scores. Findings from this unique case series are consistent with earlier reports using

between-group analyses. Conclusions Buprenorphine has the potential to become an established treatment alternative

to methadone for pregnant opioid-dependent women. Under special consideration of ethical boundaries, psychopharmacological

treatment during pregnancymust be addressed as an integral part of clinical research projects in order

to optimize treatment for women and neonates.

Organisation(en)

Institut für Klinische und Gesundheitspsychologie

Externe Organisation(en)

Johns Hopkins University, University of Maryland, College Park, Medizinische Universität Wien

Journal

Addiction

Band

106

Seiten

1355-1362

Anzahl der Seiten

ISSN

0965-2140

DOI

https://doi.org/10.1111/j.1360-0443.2011.03440.x

Publikationsdatum

2011

Peer-reviewed

ÖFOS 2012

303029 Suchtforschung, 501010 Klinische Psychologie

Schlagwörter

Link zum Portal

https://ucrisportal.univie.ac.at/de/publications/ea20a47e-df27-453a-987b-80a84a9501d5