Deceased, 14 March 2011.
Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials
Version of Record online: 22 JUL 2011
© 2011 Society for the Study of Addiction. No claim to original US government works
Volume 107, Issue 4, pages 694–708, April 2012
How to Cite
Donovan, D. M., Bigelow, G. E., Brigham, G. S., Carroll, K. M., Cohen, A. J., Gardin, J. G., Hamilton, J. A., Huestis, M. A., Hughes, J. R., Lindblad, R., Marlatt, G. A., Preston, K. L., Selzer, J. A., Somoza, E. C., Wakim, P. G. and Wells, E. A. (2012), Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials. Addiction, 107: 694–708. doi: 10.1111/j.1360-0443.2011.03473.x
- Issue online: 28 FEB 2012
- Version of Record online: 22 JUL 2011
- Submitted 15 December 2010; initial review completed 15 March 2011; final version accepted 13 April 2011
- Clinical trials;
- drug dependence;
- primary outcome;
- treatment research
Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials.
Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated.
Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials.
Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). 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.