Addictive Behaviors, Vol. 25, No. 5, pp. 785–790, 2000
Copyright © 2000 Elsevier Science Ltd.
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Pergamon
BRIEF REPORT
CHARACTERISTICS OF RESEARCH VOLUNTEERS FOR
INPATIENT COCAINE STUDIES: FOCUS ON
SELECTION BIAS
MEHMET SOFUOGLU, SUSAN DUDISH-POULSEN,
KRISTIN K. NICODEMUS, DAVID A. BABB, and
DOROTHY K. HATSUKAMI
University of Minnesota
Abstract — In order to investigate the selection bias of subjects for inpatient human cocaine
studies, characteristics of 859 potential subjects were examined. Excluded subjects compared
with accepted group were more likely to be single and male, currently use drugs other than co-
caine, have a history of intravenous cocaine use, and have medical or mental health problems
or physical complaints. Subjects who were accepted but did not participate, compared with
participants, were likely to spend more money on cocaine. These results suggest that potential
subjects who were accepted to our research studies may not accurately represent all potential
subjects for several important subject characteristics. © 2000 Elsevier Science Ltd.
Key Words. Cocaine, Crack-cocaine, Research subjects, Selection bias.
Selection bias of research subjects is important in determining the generalizability of
the results from clinical trials. For drug addiction research that uses nontreatment-
seeking research volunteers, selection bias is further complicated. The goal of this
study was to address two related questions by comparing the outcome of phone
screening of potential subjects for inpatient cocaine studies. The first question was
whether the characteristics of subjects who were accepted to our studies were different
than the characteristics of those who were excluded. Since the results obtained from
study participants are generalized to all cocaine users, it was important to understand
the differences between these two groups. The second question was whether the char-
acteristics of subjects who participated in our studies were different than the charac-
teristics of those who were accepted but did not participate (nonparticipants). This
comparison would address whether there was a self-selection bias in addition to our
selection bias. This study will extend the previous studies that investigated the charac-
teristics of research subjects for inpatient cocaine studies (Dudish & Hatsukami, 1996;
Foltin, Fischman, Cornell, & Butler, 1996; Lexau, Nelson, & Hatsukami, 1998;
Schuster & Fischman, 1985).
This research was supported by grants from National Institute on Drug Abuse (P-50 DA09259) and from
the National Center for Research Resources (MO1-RR00400). We would like to thank Robin L. Bliss for
statistical analysis and Clair Wilcox for preparing the manuscript.
Requests for reprints should be sent to Mehmet Sofuoglu, Department of Psychiatry, University of
Minnesota, Box 392 UMHC, Minneapolis, MN 55455; E-mail: sofuo001@tc.umn.edu