Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.

ABSTRACT: Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Because of the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies asses

SUBMITTER: Turk DC 

PROVIDER: S-EPMC3617214 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature