Primary outcome issues in drug dependence research.

The National Institute on Drug Abuse created the Clinical Trials Network (CTN) to bridge the gap between research and clinical practice relative to the treatment of substance use disorders in 1999. Since that date, 27 research protocols have been completed, some involving counseling approaches, some involving medication assisted treatment, and some involving both. Currently, the CTN is composed of approximately 167 treatment programs in 34 States, with multiple treatment programs across the country involved in each research protocol. It became apparent that there was no consensus about the most appropriate outcome measures to use relative to treatment efficacy or the methods to assess those outcomes, both within the CTN and across the literature in general.

A task force was approved by the Executive Committee of the CTN in November 2008 with the following goals: (1) to recommend a definition for a clinically meaningful outcome measure on drug use to be used in CTN clinical trials, and (2) to recommend a set of key questions/instruments that would be used across CTN clinical trials. This presentation will examine the conclusions of the task force and the relevance of those conclusions to substance abuse research and clinical practice.