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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, 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: ClinicalTrials.gov NCT00271219.
External Link
https://www.ncbi.nlm.nih.gov/pubmed/?term=Maternal+opioid+treatment%3A+Human+Experimental+Research+(MOTHER)+%E2%80%93+approach%2C+issues+and+lessons+learned.
Related Topics
- Behavioral Health
- Medications for Addiction Treatment (MAT)
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- Program Evaluation