This in-press article in Addiction, by Pacific Northwest Node PI Dennis Donovan and colleagues, summarizes the discussion and recommendations of a panel of treatment and research experts recently convened by NIDA to select appropriate primary outcomes for drug dependence treatment clinical trials, including the CTN, and discuss the feasibility of selecting a common outcome to be included in all or most trials.
The panel concluded that the primary outcome measure should be an indicator of drug-taking behavior, and that there is no single clinical metric that is appropriate for inclusion in most drug dependence treatment trials. The most appropriate outcome indicator for a trial will vary depending on study methods and goals (e.g. abstinence or reduction of use).
It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.
Citation: Donovan DM, Bigelow GE, Brigham GS, Carroll KM, Cohen AJ, Gardin JG, Hamilton JA, Huestis MA, Hughes JR, Lindblad R, Marlatt GA, Preston KL, Selzer JA, Somoza EC, Wakim PG, Wells EA. Primary Outcome Indices in Illicit Drug Dependence Treatment Research: Systematic Approach to Selection and Measurement of Drug Use End-Points in Clinical Trials. Addiction 2011 (in press). Find it in the CTN Dissemination Library!