Evidence map›Paper›PMID 23792283›Full record

GuidelinePain2013

Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations.

Shannon M Smith, Richard C Dart, Nathaniel P Katz, Florence Paillard, Edgar H Adams, Sandra D Comer, Aldemar Degroot, Robert R Edwards, David J Haddox, Jerome H Jaffe and 14 more

Abstract readGuidelineMeta-AnalysisSystematic Review
In one paragraph

Guideline in Pain, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 100 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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

100 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Article
  15. Article
  16. Reasoning, Contrastive, and In-Context Strategies for Opioid Use Stage Detection on Social Media.Proceedings of the ... Workshop on Patient-Oriented Language Processing · 2026
    Article
  17. Article
  18. Prescribing controlled substances in sleep medicine clinics: an overview of legal issues and best safety practices.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Review
  19. Article
  20. Review

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Shannon M SmithDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA University of Colorado School of Medicine and Rocky Mountain Poison & Drug Center, Denver Health, Denver, CO, USA Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA Focus Biocom, Durango, CO, USA Covance Market Access, Gaithersburg, MD, USA Columbia University, New York State Psychiatric Institute, New York, NY, USA Astellas Pharma, Inc., Northbrook, IL, USA Brigham & Women's Hospital, Boston, MA, USA Purdue Pharma LP, Stamford, CT, USA University of Maryland School of Medicine, Baltimore, MD, USA Centers for Disease Control and Prevention, Atlanta, GA, USA Collegium Pharmaceutical, Inc., Canton, MA, USA Department of Neurosurgery, University of Rochester, Rochester, NY, USA National Institute on Drug Abuse, Bethesda, MD, USA University of Pennsylvania, Philadelphia, PA, USA Pfizer Inc., Cary, NC, USA Horizon Pharma, Inc., Deerfield, IL, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA Janssen Scientific Affairs, LLC, Raritan, NJ, USA Harvard Medical School, Chestnut Hill, MA, USA Harvard Medical School, Boston, MA, USA Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Department of Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Richard C Dart
Nathaniel P Katz
Florence Paillard
Edgar H Adams
Sandra D Comer
Aldemar Degroot
Robert R Edwards
David J Haddox
Jerome H Jaffe
Christopher M Jones
Herbert D Kleber
Ernest A Kopecky
John D Markman
Ivan D Montoya
Charles O'Brien
Carl L Roland
Marsha Stanton
Eric C Strain
Gary Vorsanger
Ajay D Wasan
Roger D Weiss
Dennis C Turk
Robert H Dworkin

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
Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)U01FD004187 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2011 to 2014
$1.8M
Mentoring in Drug Abuse and Dual Diagnosis ResearchK24DA022288 · NIDA · MCLEAN HOSPITAL · PI WEISS, ROGER D. · 2007 to 2016
$1.8M
Oral Opioid Treatment and Psychiatric ComorbidityK23DA020681 · NIDA · BRIGHAM AND WOMEN'S HOSPITAL · PI WASAN, AJAY D · 2007 to 2011
$751k
FDA HHS U01 FD004187FDA HHS U01 FD005936NIDA NIH HHS DA031022NIDA NIH HHS DA09236NIDA NIH HHS DA16759NIDA NIH HHS K23 DA020681NIDA NIH HHS K24 DA022288NIDA NIH HHS P50 DA009236NIDA NIH HHS R01 DA016759NIDA NIH HHS R01 DA031022
6 · The paper itself

Abstract

As the nontherapeutic use of prescription medications escalates, serious associated consequences have also increased. This makes it essential to estimate misuse, abuse, and related events (MAREs) in the development and postmarketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to describe prescription drug MAREs differ depending on the purpose of the classification system, may apply to single events or ongoing patterns of inappropriate use, and are not standardized or systematically employed, thereby complicating the ability to assess MARE occurrence adequately. In a systematic review of existing prescription drug MARE terminology and definitions from consensus efforts, review articles, and major institutions and agencies, MARE terms were often defined inconsistently or idiosyncratically, or had definitions that overlapped with other MARE terms. The Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership convened an expert panel to develop mutually exclusive and exhaustive consensus classifications and definitions of MAREs occurring in clinical trials of analgesic medications to increase accuracy and consistency in characterizing their occurrence and prevalence in clinical trials. The proposed ACTTION classifications and definitions are designed as a first step in a system to adjudicate MAREs that occur in analgesic clinical trials and postmarketing adverse event surveillance and monitoring, which can be used in conjunction with other methods of assessing a treatment's abuse potential.

Indexed as

Adverse Drug Reaction Reporting SystemsClinical Trials as TopicDrug OverdoseHumansMedication ErrorsOpioid-Related DisordersPrescription Drug DiversionPrescription Drug MisuseSuicide, AttemptedTerminology as TopicClassificationClinical trialsPrescription drug abusePrescription drug misuseSystematic review

Identifiers

PMID23792283
PMCPMC5460151

What OpenQuestion holds

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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.