Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.
Pain
; 153(10): 1997-2008, 2012 Oct.
Article
in En
| MEDLINE
| ID: mdl-22770841
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 assessing (1) abuse liability, (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation, (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse, and (4) postmarketing epidemiological studies.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pain
/
Research Design
/
Practice Guidelines as Topic
/
Drug Discovery
/
Analgesics, Opioid
/
Opioid-Related Disorders
Type of study:
Clinical_trials
/
Guideline
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
Pain
Year:
2012
Document type:
Article
Affiliation country: