Human Laboratory Studies
A key element and critical point in medication development is submitting an IND application to the US Food and Drug Administration (FDA), or its equivalent in other countries, so that the drug can be tested in humans (see Box 9.3). However, this process is not unique to the development of drugs to treat addiction; it is a generic process for all new drugs for various indications. Human laboratory studies provide a means of exploring treatment targets for specific components of the addiction cycle, independent of expensive double-blind, placebo-controlled trials. Using the structure of the addiction cycle outlined in this book, human laboratory studies can provide measures for each of the addiction stages and are hypothesized to have value for predicting potential treatment efficacy in these domains (9.1, 9.2 and 9.4 ). Although the predictive validity of human laboratory models remains to be determined, ongoing studies with established medications used for addiction treatment provide another iteration of the Rosetta Stone approach with which to evaluate the validity of animal models and then use human laboratory models as a springboard for novel medication development (for further reading, see Koob, 2009).