Evidence map›Paper›PMID 38657730›Full record

Trial reportContemporary clinical trials2024

Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial.

Matisyahu Shulman, Scott Provost, Kaitlyn Ohrtman, Patricia Novo, Sarah Meyers-Ohki, Paul Van Veldhuisen, Neal Oden, Michael Otterstatter, Genie L Bailey, David Liu and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04464980 (NIDA-CTN-0100), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT04464980 phase2active not recruitingnot on this map

NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

TypeinterventionalSponsorNYU Langone HealthRan2021 to 2027Enrolled1,516ConditionsOpioid Use Disorder (OUD)ArmsSL-BUP, XR-BUP, XR-NTX, MM, MMR
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
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

13 authors at 6 institutions in 1 country.

Matisyahu ShulmanNew York State Psychiatric Institute, USA; Columbia University Irving Medical Center, USA. Electronic address: matisyahu.shulman@nyspi.columbia.edu.
Scott ProvostMass General Brigham McLean, USA.
Kaitlyn OhrtmanNew York State Psychiatric Institute, USA.
Patricia NovoNew York University Grossman School of Medicine, USA.
Sarah Meyers-OhkiNew York University Grossman School of Medicine, USA.
Paul Van VeldhuisenThe Emmes Company, LLC, USA.
Neal OdenThe Emmes Company, LLC, USA.
Michael OtterstatterThe Emmes Company, LLC, USA.
Genie L BaileyWarren Alpert School of Medicine of Brown University / Stanley Street Treatment and Resources, Inc., USA.
David LiuNational Institute on Drug Abuse, USA.
John RotrosenNew York University Grossman School of Medicine, USA.
Edward V NunesNew York State Psychiatric Institute, USA; Columbia University Irving Medical Center, USA.
Roger D WeissMass General Brigham McLean, USA.
Emmes (United States) · USNew York State Psychiatric InstituteNew York University · USMass General Brigham · USBrown University · USNational Institute on Drug Abuse · US

Funding

Project-003UG1DA013035 · NIDA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Aimee N Campbell, Jennifer McNeely · 2015 to 2026
$130.3M
The National Drug Abuse Treatment Clinical Trials NetworkUG1DA015831 · NIDA · YALE UNIVERSITY · PI Gail D'Onofrio, Roger D. Weiss · 2015 to 2026
$110.8M
NIDA NIH HHS UG1 DA013035NIDA NIH HHS UG1 DA015831
6 · The paper itself

Abstract

INTRODUCTION AND

backgroundBuprenorphine, and extended-release naltrexone, are effective in decreasing opioid use, morbidity and mortality. The available evidence suggests that these medications should be used for long term treatment; however, patients often ask how long they need to be on medication, and whether it would be safe to discontinue. There are sparse data to guide us. The CTN-0100 trial will address this gap in our knowledge by studying participants who have decided to discontinue buprenorphine and extended-release naltrexone for OUD. RESEARCH DESIGN AND

methodsThe trial is a multicenter, randomized, non-blinded study. Participants are stable adult volunteers, on sublingual buprenorphine, extended-release buprenorphine, or extended-release naltrexone, expressing an interest in discontinuing medication. Participants on buprenorphine must be stable for at least 1 year and participants on extended-release naltrexone must be stable for at least 6 months. Participants are engaged in the study for up to 96 weeks, including a flexible taper period, and are then transitioned to follow-up within the trial. All participants are randomly assigned to the study Medical Management (MM) or to MM plus Connections (CHESS health) digital smartphone application aimed at recovery and abstinence (MMD). Sublingual Buprenorphine participants are also randomized (2 × 2 design) to a taper using either sublingual or extended-release buprenorphine. DISCUSSION/

conclusionIt is hoped that this trial will provide a rich source of data on management of patients discontinuing medication for opioid use disorder (MOUD) to inform future research and practice. The trial will shed light on which strategies are most likely to lead to long-term success (absence of relapse), and what participant characteristics distinguish those who can safely discontinue MOUD from those who remain at risk of relapse should they discontinue. CLINICALTRIALS: gov Identifier: NCT04464980.

Indexed as

BuprenorphineDelayed-Action PreparationsNaltrexoneOpioid-Related DisordersAdministration, SublingualAdultFemaleHumansMaleMiddle AgedNarcotic AntagonistsOpiate Substitution TreatmentResearch DesignWithholding TreatmentBuprenorphineDelayed-Action PreparationsNaltrexoneNarcotic AntagonistsAutomated psychosocial interventionBuprenorphineNaltrexoneOpioidsOpioid use disorderTreatment

Identifiers

PMID38657730
PMCPMC11180567
OpenAlexW4395013844

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.