Human Abuse Potential: Selecting A Positive Control

Selecting the right positive control is a cornerstone of a well-designed human abuse potential (HAP) study. The choice directly shapes how confidently a test drug’s abuse liability can be interpreted, particularly as regulatory expectations emphasize meaningful, well-justified comparators. Sponsors must balance regulatory requirements with scientific rationale, identifying alternative controls that can still establish a credible benchmark through comparable subjective effects. Dose selection adds another layer of complexity, requiring evidence that the control reliably produces measurable effects distinct from placebo.

Explore practical considerations for comparator and dose selection, highlighting strategies to navigate uncertainty while maintaining study integrity and regulatory defensibility.