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Abstract:
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In a randomized double-blind, double-dummy, placebo- and positive-controlled crossover designed drug abuse potential study, there are usually at least 5 treatments, which include placebo, several doses of a test drug, and several doses of a positive control drug. Study subjects are healthy volunteers with histories of drug abuse. In such studies placebo responses are compared with responses from the positive control drug in order to validate the study, and are also compared with responses from the test drug for assessing abuse potential. FDA has suggested Sponsors to compare the mean response of a test drug to double the mean response of placebo regardless of endpoints or class of drugs. This methodology has been criticized by many Sponsors. This article addresses this issue, and proposes a new methodology in the assessment of the abuse potential of drugs.
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