Limitations of Experimental Human Abuse Liability ... - immpact

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Issues Discussed:A number of them unresolved…• An added component to traditional ALA when testing ADF’s: extractabilitytesting• What is the appropriate subject population?• When doing IN and IV ALA, should the extract from the ADF formulation beused?• What kind of ALA testing needs to be done with ADFs?• Latency to peak positive effects of IR vs. ER opioids...how much does itmatter?• What constitutes a clinically significant reduction in abuse liability of anADF?• Does ALA have predictive validity?• Have ALA instruments been validated?• Is there the need to standardize primary outcome measures in ALA?
Acknowledgments• Kenzie Preston, Ph.D.• George Bigelow, Ph.D.• Eric Strain, M.D.• Craig Rush, Ph.D.• Lynn Webster, M.D.• Sandra Comer, Ph.D.
Page 1 and 2: Limitations of Experimental HumanAb
Page 3 and 4: Issues Relating to Human ALA ofOpio
Page 5 and 6: An Added Component to Traditional A
Page 7 and 8: Major Issues Related ToExtractabili
Page 9 and 10: Extractability (Benchtop) Testing:T
Page 11 and 12: 2. What is the appropriate subject
Page 13 and 14: 2. What is the appropriate subject
Page 15 and 16: 3. When doing IN and IV ALA, should
Page 17 and 18: 3. When doing IN and IV ALA, should
Page 19 and 20: 4. What kind of ALA testing needs t
Page 21 and 22: 5. Latency to peak positive effects
Page 23 and 24: The issue of weighting due to rate
Page 25 and 26: 6. What constitutes a clinically si
Page 27 and 28: 6. What constitutes a clinically si
Page 29 and 30: Does ALA have predictive validity?
Page 31 and 32: Have ALA instruments been validated
Page 33 and 34: CPDD Expert Panels recommendation
Page 35: • BipolarDrug liking- VAS: 0= dis

Limitations of Experimental Human Abuse Liability ... - immpact

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