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Randomized Controlled Trials in Substance Abuse Treatment Research: Fundamental Aspects and New Developments in Random Assignment Strategies, Comparison/Control Conditions, and Design Characteristics

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Research Methods in the Study of Substance Abuse

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Abstract

Although not without their critics and limitations, randomized controlled trials (RCT) in clinical research are widely considered the highest methodological standard for establishing the feasibility, efficacy, and effectiveness of new and existing treatments in the field of substance abuse treatment as well as in all other areas of health-related care. This chapter reviews the basic design characteristics of RCTs after first considering the limitations of several large-scale, nonrandomized observational studies of substance abuse treatment to highlight the main benefits of the RCT design for making causal inferences. Important aspects of conducting an RCT are then discussed including: determining a research question; NIDA’s stage model of RCT studies; participant selection; choice of design; control/comparison groups; and alternative randomization strategies. Emerging issues and design developments are considered in each section. Throughout, important concepts are highlighted using examples from RCT studies many of which were conducted as part of the National Drug Abuse Treatment Clinical Trials Network (CTN), which has conducted a large number of multisite RCTs over the past 15 years. In the process, these studies have provided much valuable information not only on the efficacy–effectiveness of different substance abuse treatment interventions but also on improving RCT methodology.

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Notes

  1. 1.

    The acronym RCT can also be used to refer to randomized clinical trials when the subject area of the study is to compare clinical interventions using a randomized design. Most of the studies referenced in this paper are, in fact, randomized clinical trials for this reason. We use the term RCT in a general if technically incorrect sense to refer to both randomized controlled and randomized clinical trials throughout the chapter. All of the examples given, however, are randomized clinical trials that compare the effectiveness of one or more treatments.

  2. 2.

    Available online at: http://sites.duke.edu/rethinkingclinicaltrials/.

  3. 3.

    Arguably, this same design but without random assignment to condition is also the kind of design used most often in quasi-experimental research studies. In the quasi-experimental version, in place of random assignment, some other strategy such as matching is used to maximize the comparability of participant characteristics across the experimental conditions.

  4. 4.

    http://methodology.psu.edu/ra/smart/projects.

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  1. Jane Addams College of Social Work, University of Illinois at Chicago, Chicago, IL, USA

    James A. Swartz

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    Jonathan B. VanGeest

  2. Survey Research Laboratory, Department of Public Administration, College of Urban Planning and Public Affairs, University of Illinois at Chicago, Chicago, Illinois, USA

    Timothy P. Johnson

  3. Department of Health Policy and Management, College of Public Health, Kent State University, Kent, Ohio, USA

    Sonia A. Alemagno

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Swartz, J.A. (2017). Randomized Controlled Trials in Substance Abuse Treatment Research: Fundamental Aspects and New Developments in Random Assignment Strategies, Comparison/Control Conditions, and Design Characteristics. In: VanGeest, J., Johnson, T., Alemagno, S. (eds) Research Methods in the Study of Substance Abuse. Springer, Cham. https://doi.org/10.1007/978-3-319-55980-3_3

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