Principles of laboratory assessment of drug abuse liability and implications for clinical development

Lawrence P. Carter, Roland R. Griffiths

Research output: Contribution to journalReview articlepeer-review

144 Scopus citations


Abuse liability testing plays an important role in informing drug development, regulatory processes, and clinical practice. This paper describes the current " gold standard" methodologies that are used for laboratory assessments of abuse liability in non-human and human subjects. Particular emphasis is given to procedures such as non-human drug discrimination, self-administration, and physical dependence testing, and human dose-effect abuse liability studies that are commonly used in regulatory submissions to governmental agencies. The potential benefits and risks associated with the inclusion of measures of abuse liability in industry-sponsored clinical trials is discussed. Lastly, it is noted that many factors contribute to patterns of drug abuse and dependence outside of the laboratory setting and positive or negative signals in abuse liability studies do not always translate to high or low levels of actual abuse or dependence. Well-designed patient and physician education, pharmacovigilance, and postmarketing surveillance can reduce the diversion and misuse of drugs with abuse liability and can effectively foster the protection and promotion of public health.

Original languageEnglish (US)
Pages (from-to)S14-S25
JournalDrug and alcohol dependence
Issue numberSUPPL. 1
StatePublished - Dec 1 2009


  • Abuse liability
  • Clinical trial
  • Drug abuse
  • Drug development
  • Drug discrimination
  • Self-administration

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)


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