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

ABSTRACT:

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, pat

SUBMITTER: Jones HE 

PROVIDER: S-EPMC4497510 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature