title: 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 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.
authors: University of Washington, Seattle, Washington, USA University of Rochester, Rochester, New York, USA Johns Hopkins University, Baltimore, Maryland, USA Analgesic Solutions and Tufts University, Boston, Massachusetts, USA Covance, Conshohocken, Pennsylvania, USA Harvard Medical School, Boston, Massachusetts, USA Columbia University, New York, USA Denver Health Authority and Rocky Mountain Poison and Drug Center, Denver, Colorado, USA University of North Carolina, Chapel Hill, North Carolina, USA National Institute on Drug Abuse, Bethesda, Maryland, USA United States Food and Drug Administration, Silver Spring, Maryland, USA CNS Drug Consulting, McLean, Virginia, USA University of Chicago, Chicago, Illinois, USA Endo Pharmaceuticals, Chadds Ford, Pennsylvania, USA American Chronic Pain Association, Rocklin, California, USA AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA Brigham and Women's Hospital, Boston, Massachusetts, USA AcelRx Pharmaceuticals, Redwood City, California, USA University of Texas Health Science Center San Antonio, San Antonio, Texas, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey, USA Pfizer, New Brunswick, New Jersey, USA Clinical Research and Pain Clinic, Salt Lake City, Utah, USA NAMA Recovery, Cedar Park, Texas, USA.
authors: Dennis C
authors: DC
authors: Turk
authors: Alec B
authors: AB
authors: O'Connor
authors: Robert H
authors: RH
authors: Dworkin
authors: Amina
authors: A
authors: Chaudhry
authors: Nathaniel P
authors: NP
authors: Katz
authors: Edgar H
authors: EH
authors: Adams
authors: John S
authors: JS
authors: Brownstein
authors: Sandra D
authors: SD
authors: Comer
authors: Richard
authors: R
authors: Dart
authors: Nabarun
authors: N
authors: Dasgupta
authors: Richard A
authors: RA
authors: Denisco
authors: Michael
authors: M
authors: Klein
authors: Deborah B
authors: DB
authors: Leiderman
authors: Robert
authors: R
authors: Lubran
authors: Bob A
authors: BA
authors: Rappaport
authors: James P
authors: JP
authors: Zacny
authors: Harry
authors: H
authors: Ahdieh
authors: Laurie B
authors: LB
authors: Burke
authors: Penney
authors: P
authors: Cowan
authors: Petra
authors: P
authors: Jacobs
authors: Richard
authors: R
authors: Malamut
authors: John
authors: J
authors: Markman
authors: Edward
authors: E
authors: Michna
authors: Pamela
authors: P
authors: Palmer
authors: Sarah
authors: S
authors: Peirce-Sandner
authors: Jennifer S
authors: JS
authors: Potter
authors: Srinivasa N
authors: SN
authors: Raja
authors: Christine
authors: C
authors: Rauschkolb
authors: Carl L
authors: CL
authors: Roland
authors: Lynn R
authors: LR
authors: Webster
authors: Roger D
authors: RD
authors: Weiss
authors: Kerry
authors: K
authors: Wolf
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects* / Q000627:therapeutic use*; D055808:Drug Discovery; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D010146:Pain / Q000517:prevention & control*; D017410:Practice Guidelines as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D014481:United States
chemical_list: D000701:Analgesics, Opioid