Choosing a control group in effectiveness trials of behavioral drug abuse treatments

Received 24 September 2008; received in revised form 20 April 2009; accepted 21 May 2009. published online 25 June 2009.

Abstract

Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial's internal and external validity. The purpose of this article was to provide a discussion of the issues involved in choosing a control group for effectiveness trials of behavioral interventions in substance abuse treatment. The authors provide a description of four trial designs and a discussion of the advantages and disadvantages of each.

Keywords: Drug, Abuse, Clinical, Trial, Control, Design

a Maryhaven Research Institute, Maryhaven, Columbus, OH 43207, USA

b Department of Epidemiology and Public Health, Miller School of Medicine, University of Miami, Miami, FL 33136, USA

c Center for Clinical Trials Network, National Institute on Drug Abuse, Washington, DC 20892, USA

d Department of Psychology, University of Arizona, Tucson, AZ 85721, USA

Corresponding author. Maryhaven, 1791 Alum Creek Drive, Columbus, OH 43207, USA. Tel.: +1 614 324 5417; fax: +1 614 445 6518.

This work was supported by National Institute on Drug Abuse (U10 DA13732, U10 DA13720, 1K23 DA021512 ).

PII: S0740-5472(09)00088-9

doi:10.1016/j.jsat.2009.05.004

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