title: Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned.
abstract: OBJECTIVE
  The Maternal Opioid Treatment: Human Experimental Research (MOTHER) project, an eight-site randomized, double-blind, double-dummy, flexible-dosing, parallel-group clinical trial is described. This study is the most current--and single most comprehensive--research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine.
  
  
  METHODS
  The MOTHER study design is outlined, and its basic features are presented.
  
  
  CONCLUSIONS
  At least seven important lessons have been learned from the MOTHER study: (i) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (ii) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment, patient populations and hospital practices that, in turn, differentially impact recruitment rates, treatment compliance and attrition; (iii) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (iv) staff turnover needs to be addressed with a proactive focus on both hiring and training; (v) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (vi) timely tracking of data in a multi-site trial is both demanding and unforgiving; and (vii) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. hjones18@jhmi.edu
authors.forename: Hendrée E
authors.initials: HE
authors.lastname: Jones
authors.forename: Gabriele
authors.initials: G
authors.lastname: Fischer
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Heil
authors.forename: Karol
authors.initials: K
authors.lastname: Kaltenbach
authors.forename: Peter R
authors.initials: PR
authors.lastname: Martin
authors.forename: Mara G
authors.initials: MG
authors.lastname: Coyle
authors.forename: Peter
authors.initials: P
authors.lastname: Selby
authors.forename: Susan M
authors.initials: SM
authors.lastname: Stine
authors.forename: Kevin E
authors.initials: KE
authors.lastname: O'Grady
authors.forename: Amelia M
authors.initials: AM
authors.lastname: Arria
mesh_terms: D002047:Buprenorphine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D009357:Neonatal Abstinence Syndrome / Q000175:diagnosis* / Q000628:therapy; D058850:Opiate Substitution Treatment; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D018579:Patient Selection; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy* / Q000534:rehabilitation; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D016896:Treatment Outcome; D014481:United States
chemical_list: D009292:Narcotic Antagonists; D002047:Buprenorphine