title: Lessons learned from a comparison of evidence-based research in pregnant opioid-dependent women.
abstract: OBJECTIVE
  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 14.00 mg buprenorphine/52.50 mg methadone and MT participants at 13.44 mg buprenorphine/63.68 mg 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.
authors.affiliation: Department of Psychiatry and Psychotherapy, Medical University Vienna, Vienna, Austria. winklbaur@meduniwien.ac.at
authors.forename: Bernadette
authors.initials: B
authors.lastname: Winklbaur-Hausknost
authors.forename: Reinhold
authors.initials: R
authors.lastname: Jagsch
authors.forename: Klaudia
authors.initials: K
authors.lastname: Graf-Rohrmeister
authors.forename: Annemarie
authors.initials: A
authors.lastname: Unger
authors.forename: Andjela
authors.initials: A
authors.lastname: Baewert
authors.forename: Martin
authors.initials: M
authors.lastname: Langer
authors.forename: Kenneth
authors.initials: K
authors.lastname: Thau
authors.forename: Gabriele
authors.initials: G
authors.lastname: Fischer
mesh_terms: D000293:Adolescent; D000328:Adult; D002047:Buprenorphine / Q000627:therapeutic use; D004311:Double-Blind Method; D019317:Evidence-Based Medicine / Q000379:methods / Q000639:trends*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007858:Learning; D008691:Methadone / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000453:epidemiology*; D011256:Pregnancy Outcome / Q000453:epidemiology; D055815:Young Adult
chemical_list: D002047:Buprenorphine; D008691:Methadone