Evaluating the abuse potential of opioids and abuse-deterrent -opioid formulations: A review of clinical study methodology.

Evaluating the abuse potential of opioids and abuse-deterrent -opioid formulations: A review of clinical study methodology. J Opioid Manag. 2017 Nov/Dec;13(6):485-523 Authors: Setnik B, Schoedel KA, Levy-Cooperman N, Shram M, Pixton GC, Roland CL Abstract With the development of opioid abuse-deterrent formulations (ADFs), there is a need to conduct well-designed human abuse potential studies to evaluate the effectiveness of their deterrent properties. Although these types of studies have been conducted for many years, largely to evaluate inherent abuse potential of a molecule and inform drug scheduling, methodological approaches have varied across studies. The focus of this review is to describe current "best practices" and methodological adaptations required to assess abuse-deterrent opioid formulations for regulatory submissions. A literature search was conducted in PubMed® to review methodological approaches (study conduct and analysis) used in opioid human abuse potential studies. Search terms included a combination of "opioid," "opiate," "abuse potential," "abuse liability," "liking," AND "pharmacodynamic," and only studies that evaluated single doses of opioids in healthy, nondependent individuals with or without prior opioid experience were included. Seventy-one human abuse potential studies meeting the prespecified criteria were identified, of which 21 studies evaluated a purported opioid ADF. Based on these studies, key met...
Source: Journal of Opioid Management - Category: Addiction Tags: J Opioid Manag Source Type: research