Lessons learned from a comparison of evidence-based research in pregnant opioid-dependent women

Autor(en)

Bernadette Winklbaur-Hausknost, Reinhold Jagsch, Klaudia Graf-Rohrmeister, Annemarie Unger, Andjela Baewert, Martin Langer, Kenneth Thau, Gabriele Fischer

Abstrakt

Objectives: Lessons learned in research and treatment of opioid dependence demonstrate the need to include pregnant women in clinical trials.
Methods: Two double-blind, double-dummy, randomized controlled trials (Pilot study, European sample† of MOTHER-trial) comparing
buprenorphine and methadone in opioid-dependent pregnant women were conducted. In both studies, participants received voucher-based
incentives for attendance and completion of study assessments. In the MOTHER trial, participants additionally received escalating voucher
incentives for drug-free urine samples. Neonatal abstinence syndrome was treated with oral morphine solution based on standardized
modified Finnegan scores.
Results: After a mean treatment period of 13.79 weeks in the Pilot study (PS, n = 18) and 20.78 weeks in the MOTHER-trial (MT, n=41),
respectively (p<0.001), PS patients delivered at mean doses of 14.00mg buprenorphine/52.50mg methadone and MT participants at
13.44mg buprenorphine/63.68mg methadone. Nonsignificant differences regarding dropout rates were found (22% in PS versus 10% in MT),
but dropout was significantly earlier in the MT(p = 0.013). Significantly higher rates of concomitant consumption of opioids and benzodiazepines
occurred in the PS compared with the MT (p<0.001), however, with no significant differences in neonatal data between both settings.
Conclusions: Early treatment enrolment combined with contingency management contributes to reduced illicit drug use throughout pregnancy,
surprisingly without influencing neonatal outcome parameters.

Organisation(en)

Institut für Klinische und Gesundheitspsychologie

Externe Organisation(en)

Medizinische Universität Wien

Journal

Human Psychopharmacology: Clinical and Experimental

Band

28

Seiten

15-24

Anzahl der Seiten

10

DOI

https://doi.org/10.1002/hup.2275

Publikationsdatum

2013

Peer-reviewed

Ja

ÖFOS 2012

303029 Suchtforschung, 501010 Klinische Psychologie

Schlagwörter

Link zum Portal

https://ucrisportal.univie.ac.at/de/publications/39ece00e-4b2c-4c39-98e9-d5f81e208bd0