title: An equivalence test for the comparison between a test drug and placebo in human abuse potential studies.
abstract: Statistical methodologies for human abuse potential studies are rarely evaluated. Human abuse potential studies assess whether test drugs produce positive and negative subjective responses on abuse-related measures using volunteers with histories of recreational drug use. These studies typically have a randomized, double-blind, placebo- and positive-controlled crossover design with at least four treatments: placebo, at least two doses of a test drug, and at least one dose of a positive control drug (a drug with known abuse potential). This article proposes a new test for assessing whether a test drug produces data indicative of abuse potential when compared to placebo.
authors: Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , MD 20903 , USA. ling.chen@fda.hhs.gov
authors: Ling
authors: L
authors: Chen
authors: Katherine R
authors: KR
authors: Bonson
mesh_terms: D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D019966:Substance-Related Disorders
chemical_list: D010919:Placebos