Quantifying the abuse liability of oral nicotine products is challenging!

Abuse liability studies should assess:

• Nicotine exposure during and after product use
• How people use the product (topography)
• Subjective effects of use (e.g., product liking, urge to smoke)

Some challenges for oral products:

• Can have conflicting nicotine PK information
  • e.g., longer Tmax, but Cmax and AUC > cigarette
  • Controlled vs. ad libitum
• Longer use duration requires longer assessments
  • Controlled use: >2 hours; ad libitum: >4 hours
  • Affects the number of blood draws and collection times
  • Consider at-home use studies of urinary biomarkers
• Duration of controlled use must be justified
  • Longer controlled use increases nicotine PK (Azzopardi et al., 2025)
    • But also provides benefit to smokers
• Experience affects use topography
  • What defines experience for oral products?
• Dissolution data may support bridging argumentsSee the download for more!