Methodological and ethical aspects in conducting randomized controlled clinical trials ( RCT ) for addictive disorder ’ s interventions

According to epidemiologic reports, the harmful use of alcohol and illicit drugs has been increased among the Mexican population. This use is associated to several risks and issues that affect public health and well-being of the country. This article acknowledges the need for developing treatment models and interventions which therapeutic value is supported by scientific evidence; models that respond to the attention needs of the population affected by substance use in Mexico and that can be generalized in community clinical practice. In clinical research, randomized controlled clinical trials (RCTs) are the “gold standard” to demonstrate the effect of a therapeutic intervention. An RCT is a prospective study in which the effect, value and safety of one or various experimental interventions are tested against a “control” intervention in human subjects. Acknowledging that Mexico has a lack of research on addiction treatment complying with all the requirements to be considered as an RCT, this article presents several methodological and ethical considerations that are to be considered for their design and conduction. These considerations include from the establishment of a relevant research question and objectives to adequate study design and development of strategies for data management, statistical analysis, monitoring of interventions, safety monitoring and research quality and protection of human subjects assurance.