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

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.