Evidence map›Paper›PMID 22998781›Full record

ArticlePain2012

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations.

Sandra D Comer, James P Zacny, Robert H Dworkin, Dennis C Turk, George E Bigelow, Richard W Foltin, Donald R Jasinski, Edward M Sellers, Edgar H Adams, Robert Balster and 29 more

Abstract read
In one paragraph

Article in Pain, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
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  12. Oral Human Abuse Potential of Oxycodone DETERxJournal of clinical pharmacology · 2017
    Trial
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  15. Article
  16. Article
  17. Article
  18. The influence of drug class on reward in substance use disorders.Pharmacology, biochemistry, and behavior · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 1 country.

Sandra D ComerDivision on Substance Abuse, New York State Psychiatric Institute/College of Physicians and Surgeons, Columbia University, New York, NY, USA Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA Department of Anesthesiology, University of Rochester, Rochester, NY, USA Department of Anesthesiology, University of Washington, Seattle, WA, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA Department of Medicine, Johns Hopkins University, Baltimore, MD, USA Kendle Early Phase Toronto, Formerly Decision Line Clinical Research Corporation, Toronto, Ontario, Canada Covance, Princeton, NJ, USA Institute for Drug and Alcohol Studies, Virginia Commonwealth University, Richmond, VA, USA United States Food and Drug Administration, Silver Spring, MD, USA Colucci and Associates LLC, Newtown, CT, USA American Chronic Pain Association, Rocklin, CA, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Purdue Pharma L.P., Stamford, CT, USA Pfizer Inc., New London, CT, USA Psychiatry and Behavioral Sciences, Wayne State University, Detroit, MI, USA Eisai Limited, Woodcliff Lake, NJ, USA Analgesic Research, Needham, MA, USA Department of Anesthesiology, Tufts University, Boston, Massachusetts, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA CNS Drug Consulting LLC, McLean, VA, USA Department of Biostatistics, University of Rochester, Rochester, NY, USA Department of Neurology, University of Rochester, Rochester, NY, USA Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA Department of Medicine, University of Rochester, Rochester, NY, USA AcelRx Pharmaceuticals Inc., Redwood City, CA, USA Department of Anesthesiology and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA Johnson and Johnson Pharmaceutical Research and Development LLC, Raritan, NJ, USA Research Institute, California Pacific Medical Center, San Francisco, CA, USA Clinical Pharmacology and Therapeutics Laboratory, Faculdade de Medicina de Lisboa, Lisbon, Portugal King Pharmaceuticals Inc., Cary, NC, USA Grünenthal USA Inc., Bedminster, NJ, USA Durect Corporation, Cupertino, CA, USA Department of Behavioral Science, Center on Drug and Alcohol Research, University of Kentucky, KY, USA.
James P Zacny
Robert H Dworkin
Dennis C Turk
George E Bigelow
Richard W Foltin
Donald R Jasinski
Edward M Sellers
Edgar H Adams
Robert Balster
Laurie B Burke
Igor Cerny
Robert D Colucci
Edward Cone
Penney Cowan
John T Farrar
David J Haddox
Jennifer A Haythornthwaite
Sharon Hertz
Gary W Jay
Chris-Ellyn Johanson
Roderick Junor
Nathaniel P Katz
Michael Klein
Ernest A Kopecky
Deborah B Leiderman
Michael P McDermott
Charles O'Brien
Alec B O'Connor
Pamela P Palmer
Srinivasa N Raja
Bob A Rappaport
Christine Rauschkolb
Michael C Rowbotham
Cristina Sampaio
Beatrice Setnik
Marta Sokolowska
Joseph W Stauffer
Sharon L Walsh
United States Food and Drug Administration · USJohns Hopkins Medicine · USJohns Hopkins University · USUniversity of Rochester · USUniversity of Pennsylvania · USAcelRx Pharmaceuticals (United States) · USAmerican Chronic Pain AssociationCalifornia Pacific Medical Center · USCNS Research (United States) · USColumbia University · USCovance (United States) · USDurect (United States) · USEisai (United States) · USEndo Pharmaceuticals (United States) · USJohnson & Johnson (United States) · USPfizer (United States) · USPurdue Pharma (United States) · USTufts University · USUniversity of Chicago · USUniversity of Kentucky · US

Funding

PHARMACOLOGICAL TREATMENT OF MARIJUANA DEPENDENCEP50DA009236 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI KLEBER, HERBERT DAVID · 1994 to 2013
$39.4M
Prescription Opioid Effects in Drug and Non-drug AbusersR01DA016759 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI COMER, SANDRA D · 2003 to 2014
$5.0M
Pioglitazone for the Treatment of Opioid and of Nicotine DependenceR01DA031022 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI BISAGA, ADAM, COMER, SANDRA D · 2010 to 2013
$3.5M
Clinical and Preclinical Models in Drug Abuse: Training and DevelopmentK05DA031749 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI FOLTIN, RICHARD W · 2011 to 2015
$641k
NIDA NIH HHS K05 DA031749NIDA NIH HHS P50 DA009236NIDA NIH HHS R01 DA016759NIDA NIH HHS R01 DA031022
6 · The paper itself

Abstract

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL have the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing the abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided, and those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are then discussed. These outcome measures include the following: subjective effects (some of which comprise the primary outcome measures, including drug liking; physiological responses; drug self-administration behavior; and cognitive and psychomotor performance. Before presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed.

Indexed as

Practice Guidelines as TopicAnalgesics, OpioidClinical Trials as TopicHumansInternationalityNeurologyOpioid-Related DisordersOutcome Assessment, Health CareRisk AssessmentAnalgesics, Opioid

Identifiers

PMID22998781
PMCPMC3494795
OpenAlexW1990223458

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.