Evidence map›Paper›PMID 36449315›Full record

ReviewJAMA psychiatry2023

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review.

Brian D Kiluk, Bethea A Kleykamp, Sandra D Comer, Roland R Griffiths, Andrew S Huhn, Matthew W Johnson, Kyle M Kampman, Marco Pravetoni, Kenzie L Preston, Ryan Vandrey and 17 more

Open access · greenAbstract readReview
In one paragraph

Review in JAMA psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
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

27 authors at 16 institutions in 1 country.

Brian D KilukDepartment of Psychiatry, Yale School of Medicine, New Haven, Connecticut.
Bethea A KleykampUniversity of Rochester School of Medicine and Dentistry, Rochester, New York.
Sandra D ComerDivision on Substance Use Disorders, New York State Psychiatric Institute, New York.
Roland R GriffithsDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Andrew S HuhnDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Matthew W JohnsonDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Kyle M KampmanDepartment of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Marco PravetoniDepartment of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Harborview Medical Center, Seattle.
Kenzie L PrestonClinical Pharmacology and Therapeutics Research Branch, National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland.
Ryan VandreyDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Cecilia L BergeriaDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Michael P BogenschutzDepartment of Psychiatry, NYU Grossman School of Medicine, New York University, New York.
Randall T BrownDepartment of Family Medicine and Community Health, University of Wisconsin-Madison School of Medicine and Public Health, Madison.
Kelly E DunnDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Robert H DworkinUniversity of Rochester School of Medicine and Dentistry, Rochester, New York.
Patrick H FinanDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Peter S HendricksDepartment of Health Behavior, School of Public Health, University of Alabama at Birmingham.
Elisabeth J HoutsmullerPatient-Centered Outcomes Research Institute, Washington, DC.
Thomas R KostenBaylor College of Medicine, Houston, Texas.
Dustin C LeeDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Frances R LevinDivision on Substance Use Disorders, New York State Psychiatric Institute, New York.
Aimee McRae-ClarkDepartment of Psychiatry, Medical University of South Carolina, Charleston.
Charles L RaisonDepartment of Human Development and Family Studies, School of Human Ecology, University of Wisconsin-Madison.
Kurt RasmussenDelix Therapeutics, Bedford, Massachusetts.
Dennis C TurkUniversity of Washington School of Medicine, Seattle.
Roger D WeissDivision of Alcohol, Drugs, and Addiction, McLean Hospital, Belmont, Massachusetts.
Eric C StrainDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Johns Hopkins University · USJohns Hopkins Medicine · USUniversity of Rochester · USUniversity of Washington · USUniversity of Wisconsin–Madison · USBaylor College of Medicine · USColumbia University Irving Medical Center · USHarvard University · USMedical University of South Carolina · USNational Institutes of Health · USNew York State Psychiatric InstituteNew York University · USPatient-Centered Outcomes Research Institute · USUniversity of Alabama at Birmingham · USUniversity of Pennsylvania · USYale University · US

Funding

Vaccines for fentanyl and its derivatives: A strategy to reduce illicit use and overdoseUH3DA048386 · NIDA · UNIVERSITY OF WASHINGTON · PI PRAVETONI, MARCO · 2022 to 2024
$11.0M
Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine ComponentsUG3DA047711 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI COMER, SANDRA D, PRAVETONI, MARCO · 2018 to 2019
$9.4M
Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine ComponentsUH3DA047711 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI SANDRA D. COMER, Marco Pravetoni · 2023 to 2026
$7.3M
Vaccines for fentanyl and its derivatives: A strategy to reduce illicit use and overdoseUG3DA048386 · NIDA · UNIVERSITY OF MINNESOTA · PI PRAVETONI, MARCO · 2019 to 2020
$3.3M
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
Development of the Stimulant Use Disorder Severity ScaleU01DA051639 · NIDA · YALE UNIVERSITY · PI KILUK, BRIAN D. · 2020 to 2023
$1.8M
Integrating Cognitive Neuroscience Toward Understanding of Mechanisms of CBT for Alcohol Use DisordersK02AA027300 · NIAAA · YALE UNIVERSITY · PI KILUK, BRIAN D. · 2019 to 2023
$719k
FDA HHS U01 FD005936NIAAA NIH HHS K02 AA027300NIDA NIH HHS U01 DA051639NIDA NIH HHS UG3 DA047711NIDA NIH HHS UG3 DA048386NIDA NIH HHS UH3 DA047711NIDA NIH HHS UH3 DA048386
6 · The paper itself

Abstract

Importance: Novel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous μ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In November 2019, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration sponsored a meeting to discuss the current evidence regarding potential treatments for OUD, including cannabinoids, psychedelics, sedative-hypnotics, and immunotherapeutics, such as vaccines. Observations: Consensus recommendations are presented regarding the most critical elements of trial design for the evaluation of novel OUD treatments, such as: (1) stage of treatment that will be targeted (eg, seeking treatment, early abstinence/detoxification, long-term recovery); (2) role of treatment (adjunctive with or independent of existing OUD treatments); (3) primary outcomes informed by patient preferences that assess opioid use (including changes in patterns of use), treatment retention, and/or global functioning and quality of life; and (4) adverse events, including the potential for opioid-related relapse or overdose, especially if the patient is not simultaneously taking maintenance MOR agonist or antagonist medications. Conclusions and Relevance: Applying the recommendations provided here as well as considering input from people with lived experience in the design phase will accelerate the development, translation, and uptake of effective and safe therapeutics for individuals struggling with OUD.

Indexed as

BuprenorphineOpioid-Related DisordersAnalgesics, OpioidClinical Trials as TopicHumansOpiate Substitution TreatmentQuality of LifeAnalgesics, OpioidBuprenorphine

Identifiers

PMID36449315
PMCPMC10297827
OpenAlexW4310422008

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.