TY - JOUR
T1 - Abuse liability assessment of anxiolytics/ hypnotics
T2 - rationale and laboratory lore
AU - EVANS, SUZETTE M.
AU - CRITCHFIELD, THOMAS S.
AU - GRIFFITHS, ROLAND R.
N1 - Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.
PY - 1991/12
Y1 - 1991/12
N2 - This paper describes the rationale, practical details, and laboratory lore relevant to conducting an acute dose‐effect crossover evaluation for abuse liability of a novel anxiolytic/hypnotic compound relative to a standard compound. Basic principles underlying meaningful abuse liability assessments are presented and illustrated with examples from a comparative evaluation of the hypnotics zolpidem and triazolam. These principles include using a double‐blind placebo‐controlled design, selecting an appropriate comparison compound, evaluating a wide range of doses including supratherapeutic doses, using subjects with histories of sedative drug abuse, and using a range of dependent measures. The dose‐effect crossover evaluation is proposed as a crucial first step in any rigorous drug abuse liability evaluation of a novel anxiolytic or hypnotic drug. Such a study can be expected to generate a broad data base which not only provides a prediction about the likelihood of abuse of the novel compound, but provides an assessment of some of the adverse consequences of recreational abuse. The crossover study also establishes parameters for subsequent studies such as direct assessment of reinforcing effects with drug self‐administration testing.
AB - This paper describes the rationale, practical details, and laboratory lore relevant to conducting an acute dose‐effect crossover evaluation for abuse liability of a novel anxiolytic/hypnotic compound relative to a standard compound. Basic principles underlying meaningful abuse liability assessments are presented and illustrated with examples from a comparative evaluation of the hypnotics zolpidem and triazolam. These principles include using a double‐blind placebo‐controlled design, selecting an appropriate comparison compound, evaluating a wide range of doses including supratherapeutic doses, using subjects with histories of sedative drug abuse, and using a range of dependent measures. The dose‐effect crossover evaluation is proposed as a crucial first step in any rigorous drug abuse liability evaluation of a novel anxiolytic or hypnotic drug. Such a study can be expected to generate a broad data base which not only provides a prediction about the likelihood of abuse of the novel compound, but provides an assessment of some of the adverse consequences of recreational abuse. The crossover study also establishes parameters for subsequent studies such as direct assessment of reinforcing effects with drug self‐administration testing.
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U2 - 10.1111/j.1360-0443.1991.tb01757.x
DO - 10.1111/j.1360-0443.1991.tb01757.x
M3 - Article
C2 - 1686197
AN - SCOPUS:0026410185
SN - 0952-0481
VL - 86
SP - 1625
EP - 1632
JO - British Journal of Addiction
JF - British Journal of Addiction
IS - 12
ER -