Evidence map›Paper›PMID 36693589›Full record

ArticleContemporary clinical trials2023

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial.

Kevin E Vowles, Katie Witkiewitz, Erik Clarke, Zachary Schmidt, Brian Borsari, Karlyn E Edwards, J Richard Korecki, David I Moniz-Lewis, Juliana A Bondzie, Chloe Mullins and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04648228 (Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 35% 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.

NCT04648228 naactive not recruitingnot on this map

Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder

TypeinterventionalSponsorUniversity of New MexicoRan2021 to 2026Enrolled157ConditionsChronic Pain, Opioid-use Disorder, Opioids, Harmful UseArmsACT+MBRP, Education control
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

24 authors at 9 institutions in 2 countries.

Kevin E VowlesSchool of Psychology, Queen's University Belfast, Belfast, Northern Ireland, UK. Electronic address: k.vowles@qub.ac.uk.
Katie WitkiewitzDepartment of Psychology, University of New Mexico, Albuquerque, NM, USA. Electronic address: katiew@unm.edu.
Erik ClarkePuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Zachary SchmidtRaymond G. Murphy Veterans Affairs Medical Center, New Mexico Veteran Affairs Healthcare System, Albuquerque, NM, USA.
Brian BorsariSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Karlyn E EdwardsDepartment of Anesthesiology, Perioperative, and Pain Medicine, Division of Pain Medicine Stanford University, Palo Alto, CA, USA.
J Richard KoreckiDepartment of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.
David I Moniz-LewisDepartment of Psychology, University of New Mexico, Albuquerque, NM, USA.
Juliana A BondziePuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Chloe MullinsRaymond G. Murphy Veterans Affairs Medical Center, New Mexico Veteran Affairs Healthcare System, Albuquerque, NM, USA.
Claire I ThoresonPuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Joannalyn DelacruzSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Consuelo H WilkinsVanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, TN, USA.
Sarah NelsonVanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, TN, USA.
Jennifer DelventuraPuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Ryan HendersonPuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Andrea KatzPuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
William HuaSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Erin WatsonSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Catherine BaxleySan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Bernard R CanlasPuget Sound Veterans Affairs Healthcare Administration, Tacoma, WA, USA.
Tiffany PendletonRaymond G. Murphy Veterans Affairs Medical Center, New Mexico Veteran Affairs Healthcare System, Albuquerque, NM, USA.
Ellen HerbstSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
Steven BatkiSan Francisco Veteran Affairs Medical Center and University of California - San Francisco, San Francisco, CA, USA.
University of Puget Sound · USUniversity of California, San Francisco · USRaymond G. Murphy VA Medical Center · USSan Francisco VA Medical Center · USUniversity of New Mexico · USVanderbilt University · USQueen's University Belfast · GBStanford Medicine · USUniversity of California, Los Angeles · US

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., HERNANDEZ, ADRIAN · 2016 to 2022
$177.0M
Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
HEAL Sickle Cell and CDE SupplementU24TR004315 · NCATS · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI DWYER, JAMIE P., SWARD, KATHERINE ANN · 2022 to 2025
$13.8M
INTEGRATED TREATMENT FOR VETERANS WITH CO-OCCURRING CHRONIC PAIN AND OPIOID USE DISORDERUH3DA051241 · NIDA · UNIVERSITY OF NEW MEXICO · PI VOWLES, KEVIN E, WITKIEWITZ, KATIE A · 2020 to 2024
$2.6M
Integrated Treatment for Veterans with Co-Occurring Chronic Pain and Opioid Use DisorderUG3DA051241 · NIDA · UNIVERSITY OF NEW MEXICO · PI VOWLES, KEVIN E, WITKIEWITZ, KATIE A · 2019 to 2019
$556k
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001597NCATS NIH HHS U24 TR001608NCATS NIH HHS U24 TR001609NCATS NIH HHS U24 TR004315NIDA NIH HHS UG3 DA051241NIDA NIH HHS UH3 DA051241
6 · The paper itself

Abstract

backgroundChronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment.

methodsA multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms.

conclusionThis study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD.

trial registrationClinicalTrials.gov Identifier: NCT04648228.

Indexed as

Acceptance and Commitment TherapyBuprenorphineChronic PainOpioid-Related DisordersVeteransAdultAgedAnalgesics, OpioidHumansMiddle AgedRandomized Controlled Trials as TopicYoung AdultAnalgesics, OpioidBuprenorphineAcceptance and commitment therapyChronic painMedication for opioid use disorder (MOUD)Mindfulness-based relapse preventionOpioid use disorderPain educationVeterans

Identifiers

PMID36693589
PMCPMC10308452
OpenAlexW4318024961

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.