Evidence map›Paper›PMID 39177194›Full record

ArticleClinical and translational science2024

Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators.

Todd C Skaar, Rachel A Myers, Roger B Fillingim, John T Callaghan, Emily Cicali, Michael T Eadon, Erica N Elwood, Geoffrey S Ginsburg, Sheryl Lynch, Khoa A Nguyen and 21 more

2 registry-linked trialsAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT04445792 nacompletednot on this map

A Depression and Opioid Pragmatic Trial in Pharmacogenetics

TypeinterventionalSponsorDuke UniversityRan2021 to 2024Enrolled4,284ConditionsDepression, Acute Pain, Chronic PainArmsPharmacogenetic testing, Clinical decisions support
NCT05966142 nacompletednot on this map

A Depression and Opioid Pragmatic Trial in Pharmacogenetics

TypeinterventionalSponsorDuke UniversityRan2021 to 2024Enrolled1,048ConditionsChronic PainArmsPharmacogenetic testing, Clinical decisions support
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
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  3. Associations ofPharmaceuticals (Basel, Switzerland) · 2026
    Article
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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

31 authors.

Todd C SkaarDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0002-3849-374X
Rachel A MyersDepartment of Medicine, Clinical Research Unit, Duke University School of Medicine, Duke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0003-0086-8339
Roger B FillingimDepartment of Community Dentistry and Behavioral Science, University of Florida College of Dentistry, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0002-7699-8183
John T CallaghanDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Emily CicaliDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0002-3595-9321
Michael T EadonDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0003-3066-2876
Erica N ElwoodDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Geoffrey S GinsburgAll of Us Research Program, National Institutes of Health, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0003-4739-9808
Sheryl LynchDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0002-3842-4971
Khoa A NguyenDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0001-6518-8655
Aniwaa Owusu ObengPharmacy Department, Mount Sinai Health System, New York, New York, USA.ORCID https://orcid.org/0000-0002-1324-2573
Haesuk ParkDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0003-3299-8111
Victoria M PrattDepartment of Medical & Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0003-2871-5051
Marc RosenmanDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Azita SadeghpourDuke Precision Medicine Program, Department of Medicine, Duke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0002-3804-5453
Saskia ShumanThe Institute for Family Health, New York, New York, USA.
Rajbir SinghDepartment of Medicine, Meharry Medical College, Nashville, Tennessee, USA.
Emma M TillmanDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0001-8019-9811
Simona VolpiDivision of Genomic Medicine, National Human Genome Research Institute, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0002-0353-2235
Kristin WiisanenDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Almut G WintersteinDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0002-6518-5961
Carol R HorowitzInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.ORCID https://orcid.org/0000-0003-1517-4700
Deepak VooraDuke Precision Medicine Program, Department of Medicine, Duke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0003-0015-5179
Lori OrlandoDuke Precision Medicine Program, Department of Medicine, Duke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0003-2534-7855
Hrishikesh ChakrabortyDepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.ORCID https://orcid.org/0000-0001-9078-845X
Sara Van DriestDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID https://orcid.org/0000-0003-2580-1405
Josh F PetersonDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID https://orcid.org/0000-0002-7553-0749
Larisa A CavallariDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0002-7184-5292
Julie A JohnsonDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0001-9847-1932
Paul R DexterDepartment of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0002-0399-0156
IGNITE Pragmatic Trials Network

Funding

Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.U01HG010245 · NHGRI · INDIANA UNIVERSITY INDIANAPOLIS · PI DEXTER, PAUL, SKAAR, TODD C. · 2018 to 2024
$9.4M
NHGRI NIH HHS U01 HG010245
6 · The paper itself

Abstract

Chronic pain is a prevalent condition with enormous economic burden. Opioids such as tramadol, codeine, and hydrocodone are commonly used to treat chronic pain; these drugs are activated to more potent opioid receptor agonists by the hepatic CYP2D6 enzyme. Results from clinical studies and mechanistic understandings suggest that CYP2D6-guided therapy will improve pain control and reduce adverse drug events. However, CYP2D6 is rarely used in clinical practice due in part to the demand for additional clinical trial evidence. Thus, we designed the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) chronic pain study, a multicenter, pragmatic, randomized controlled clinical trial, to assess the effect of CYP2D6 testing on pain management. The study enrolled 1048 participants who are taking or being considered for treatment with CYP2D6-impacted opioids for their chronic pain. Participants were randomized to receive immediate or delayed (by 6 months) genotyping of CYP2D6 with clinical decision support (CDS). CDS encouraged the providers to follow the CYP2D6-guided trial recommendations. The primary study outcome is the 3-month absolute change in the composite pain intensity score assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Follow-up will be completed in July 2024. Herein, we describe the design of this trial along with challenges encountered during enrollment.

Indexed as

Analgesics, OpioidChronic PainCytochrome P-450 CYP2D6AdultFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPain ManagementPain MeasurementPharmacogenomic TestingPragmatic Clinical Trials as TopicPrecision MedicineRandomized Controlled Trials as TopicAnalgesics, OpioidCytochrome P-450 CYP2D6

Identifiers

PMID39177194
PMCPMC11342225

What OpenQuestion holds

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Registered trials

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.