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Abstract:
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The design of a human abuse potential study includes a screening visit, a Qualification Phase, a Treatment Phase and a Follow Up. The Qualification Phase is to select subjects who respond to positive control but not respond to placebo for the treatment phase. There are two treatments, positive control and placebo, in the Qualification Phase. A subject receives these treatments in a crossover manner. For the sensitivity and integrity of the study, the first comparison for the primary endpoint, Drug Liking Emax,in the Treatment Phase is between positive control and placebo. If the mean of positive control is significantly greater than that of placebo by a pre-specified margin ?1, the study is validated. Otherwise, the study fails. The commonly used ?1 is 15 for Drug Liking on a bipolar visual analog scale. Recently, we have heard some complaints regarding the margin of 15, and were told that some studies failed the validation test, because the margin 15 is too large. In this presentation, I will discuss the reasons for failing the validation test, and also make a suggestion for improving the design of the Qualification Phase in human abuse potential studies.
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