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Participants
Agenda
Background Materials
  • IMMPACT-XII Slide Presentations

  • 1. Meeting objectives and deliverables
  • Sandra Comer, PhD and James Zacny, PhD
  • 2. General considerations in developing and evaluating outcome measures of abuse liability
  • Laurie Burke, RPh, MPH
  • 3. A historical perspective on human abuse liability studies
  • Donald Jasinski, MD
  • 4. Physiologic outcome measures
  • Edward Sellers, MD, PhD
  • 5. Performance outcomes measures
  • James Zacny, PhD
  • 6. Subjective outcome measures
  • George Bigelow, PhD
  • 7. Behavioral outcome measures
  • Sandra Comer, PhD
  • 8. Data analysis
  • Richard Foltin, PhD
  • 9. A regulatory perspective on what is needed for evaluating abuse liability in analgesic clinical trials
  • Bob Rappaport, MD
  • 10. Toward a classification of abuse-related outcomes
  • Nat Katz, MD
  • 11. Clinical assessment of abuse-related outcomes
  • Charles O'Brien, MD, PhD
  • 12. Patient-reported and interviewer-rated abuse-related outcomes (e.g., COMM, ABC)
  • Jennifer Haythornthwaite, PhD
  • 13. Urine drug screening in analgesic clinical trials
  • Gary Reisfield, MD
  • 14. Study drug monitoring and diversion in analgesic clinical trials
  • Robert Colucci, PharmD
  • 15. The development of the Columbia Classification Algorithm of Suicide Assessment (C-CASA)
  • Kelly Posner, PhD
  • 16. Retrospective and prospective classification of abuse-related adverse events in analgesic clinical trials
  • Nat Katz, MD
  • 17. Discussant: FDA abuse liability review
  • Michael Klein, MD