Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned

Addiction. 2012 Nov;107 Suppl 1(0 1):28-35. doi: 10.1111/j.1360-0443.2012.04036.x.


Aims: 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.

Trial registration: NCT00271219.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Buprenorphine / administration & dosage
  • Buprenorphine / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant, Newborn
  • Narcotic Antagonists / administration & dosage
  • Narcotic Antagonists / therapeutic use*
  • Neonatal Abstinence Syndrome / diagnosis*
  • Neonatal Abstinence Syndrome / therapy
  • Opiate Substitution Treatment*
  • Opioid-Related Disorders / drug therapy*
  • Opioid-Related Disorders / rehabilitation
  • Patient Selection
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Complications / rehabilitation
  • Randomized Controlled Trials as Topic / methods
  • Treatment Outcome
  • United States


  • Narcotic Antagonists
  • Buprenorphine

Associated data