The human abuse potential study is an important part of the assessment of abuse potential of drugs. This type of study has multiple treatments and multiple abuse potential measures. The study is crossover and often uses a Williams square design. Data are collected for treatments from each treatment sequence and during each treatment period at many time points. This article proposes the use of heat maps to display complicated data sets. This graphic method provides a visual tool for exploring data from individual subjects and overall pictures of subject responses in human abuse potential studies.
US Drug Enforcement Administration. Title 21 – food and drugs, chapter 13 – drug abuse prevention and control, subchapter I – control and enforcement, Part B – authority to control; standards and schedules; 21 USC Sec. 812 (2002).
2.
WilliamsEJ. Experimental designs balanced for the estimation of residual effects of treatments. Australian Journal of Scientific Research1949;2:149–168.
3.
ChenLTsongY.Design and analysis for drug abuse potential studies: Issues and strategies for implementing a crossover design. Drug Information Journal. 2007;41(4):481–489.
4.
US FDA draft guidance for industry: assessment of the abuse potential of drugs; 2010.
5.
SneathPHA. The application of computers to taxonomy. J Gen Microbiol. 1957;17(1):201–226.
6.
NortonJD. A longitudinal model and graphic for benefit-risk analysis, with case study. Drug Information Journal. 2010;47:741–747.
7.
ByronJKenwardMG. Design and Analysis of Cross-Over Trials. 2nd ed. London: Chapman & Hall/CRC; 2003.
8.
HaertzenCA. Development of scales based on patterns of drug effects, using the Addition Research Center Inventory (ARCI). Psychol Rep. 1966;18:163–194.
9.
HaertzenCAHickeyJE. Addiction Research Center Inventory (ARCI): measurement of euphoria and other drug effects. In:
BozarthMA, eds., Methods of Assessing the Reinforcing Properties of Abused Drugs. New York: Springer-Verlag; 1987:489–524.
10.
GriffithsRRBigelowGEAtorNA. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 2003;70:S41–S54.
11.
ColeJOOrzackMHBeakeBBirdMBar-TalY.Assessment of the abuse liability of buspirone in recreational sedative users. J Clin Psychiatry. 1982;43(12 Pt 2):69–75.
