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Related Experiment Videos

Assessing abuse liability in clinical trials.

Kathleen T Brady1, R Bruce Lydiard, Joseph V Brady

  • 1Department of Psychiatry, Ralph H. Johnson Medical Center, Medical University of South Carolina (MUSC/CTN), 109 Bee Street, Charleston, SC 29401, USA. bradyk@musc.edu

Drug and Alcohol Dependence
|May 22, 2003
PubMed
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Registration-focused clinical trials can offer early insights into drug abuse liability. However, systematic data collection on subjective effects and discontinuation symptoms is needed for better assessment.

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Development

Background:

  • Registration-focused clinical trials are the first human exposure for most new compounds.
  • Current data collection on drug abuse liability in these trials is often unsystematic.
  • Subjective effects and discontinuation symptoms are typically reported as adverse events (AEs) without standardized ratings.

Purpose of the Study:

  • To discuss the utility of registration-focused clinical trials for assessing drug abuse liability.
  • To propose strategies for improving the collection of abuse liability data within these trials.
  • To highlight the need for validated instruments and threshold determination for abuse potential.

Main Methods:

  • Discussion of current practices in registration-focused clinical trials.

Related Experiment Videos

  • Analysis of limitations in collecting abuse liability data.
  • Proposal of strategies for enhanced data collection on subjective effects and discontinuation symptoms.

    • Main Results:

    • Registration-focused trials have inherent limitations (small sample size, participant exclusion) for abuse liability assessment.
    • Systematic collection of subjective effects and discontinuation symptoms is currently lacking.
    • Existing methods often fail to capture crucial abuse liability indicators like drug 'liking'.

    Conclusions:

    • Registration-focused trials offer a valuable, albeit limited, opportunity to gather early drug abuse liability information.
    • Implementing standardized assessment tools and systematic data collection is crucial for improving insights.
    • Dedicated studies are essential for drugs with suspected abuse potential, especially in vulnerable populations.