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; Joannalyn Delacruz; Consuelo H Wilkins; Sarah Nelson; Jennifer Delventura; Ryan Henderson; Andrea Katz; William Hua; Erin Watson; Catherine Baxley; Bernard R Canlas; Tiffany Pendleton; Ellen Herbst; Steven Batki

doi:10.1016/j.cct.2023.107096

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, Joannalyn Delacruz, Consuelo H Wilkins, Sarah Nelson, Jennifer Delventura, Ryan Henderson, Andrea Katz, William Hua, Erin Watson, Catherine Baxley, Bernard R CanlasTiffany Pendleton, Ellen Herbst, Steven Batki

^*Corresponding author for this work

School of Psychology

Research output: Contribution to journal › Article › peer-review

12 Downloads (Pure)

Abstract

Background
Chronic 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.

Methods
A 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.

Conclusion
This 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 registration
ClinicalTrials.gov Identifier: NCT04648228

Original language	English
Article number	107096
Number of pages	8
Journal	Contemporary Clinical Trials
Volume	126
Early online date	01 Feb 2023
DOIs	https://doi.org/10.1016/j.cct.2023.107096
Publication status	Published - Mar 2023

Keywords

Acceptance and commitment therapy
Chronic pain
Medication for opioid use disorder (MOUD)
Mindfulness-based relapse prevention
Opioid use disorder
Pain education
Veterans

Access to Document

10.1016/j.cct.2023.107096Licence: CC BY

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
2023 Crown Copyright This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 510 KBLicence: CC BY

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

Vowles, K. E., Witkiewitz, K., Clarke, E., Schmidt, Z., Borsari, B., Edwards, K. E., Korecki, J. R., Moniz-Lewis, D. I., Bondzie, J. A., Mullins, C., Delacruz, J., Wilkins, C. H., Nelson, S., Delventura, J., Henderson, R., Katz, A., Hua, W., Watson, E., Baxley, C., ... Batki, S. (2023). 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. Contemporary Clinical Trials, 126, [107096]. https://doi.org/10.1016/j.cct.2023.107096

@article{5c035d86c6df4648a7f4e304c052ab26,

title = "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",

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",

keywords = "Acceptance and commitment therapy, Chronic pain, Medication for opioid use disorder (MOUD), Mindfulness-based relapse prevention, Opioid use disorder, Pain education, Veterans",

author = "Vowles, {Kevin E.} and Katie Witkiewitz and Erik Clarke and Zachary Schmidt and Brian Borsari and Edwards, {Karlyn E} and Korecki, {J Richard} and Moniz-Lewis, {David I} and Bondzie, {Juliana A} and Chloe Mullins and Joannalyn Delacruz and Wilkins, {Consuelo H} and Sarah Nelson and Jennifer Delventura and Ryan Henderson and Andrea Katz and William Hua and Erin Watson and Catherine Baxley and Canlas, {Bernard R} and Tiffany Pendleton and Ellen Herbst and Steven Batki",

year = "2023",

month = mar,

doi = "10.1016/j.cct.2023.107096",

language = "English",

volume = "126",

journal = "Contemporary Clinical Trials",

issn = "1551-7144",

publisher = "Elsevier",

}

Vowles, KE, Witkiewitz, K, Clarke, E, Schmidt, Z, Borsari, B, Edwards, KE, Korecki, JR, Moniz-Lewis, DI, Bondzie, JA, Mullins, C, Delacruz, J, Wilkins, CH, Nelson, S, Delventura, J, Henderson, R, Katz, A, Hua, W, Watson, E, Baxley, C, Canlas, BR, Pendleton, T, Herbst, E & Batki, S 2023, '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', Contemporary Clinical Trials, vol. 126, 107096. https://doi.org/10.1016/j.cct.2023.107096

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. / Vowles, Kevin E.; Witkiewitz, Katie; Clarke, Erik et al.

In: Contemporary Clinical Trials, Vol. 126, 107096, 03.2023.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Vowles, Kevin E.

AU - Witkiewitz, Katie

AU - Clarke, Erik

AU - Schmidt, Zachary

AU - Borsari, Brian

AU - Edwards, Karlyn E

AU - Korecki, J Richard

AU - Moniz-Lewis, David I

AU - Bondzie, Juliana A

AU - Mullins, Chloe

AU - Delacruz, Joannalyn

AU - Wilkins, Consuelo H

AU - Nelson, Sarah

AU - Delventura, Jennifer

AU - Henderson, Ryan

AU - Katz, Andrea

AU - Hua, William

AU - Watson, Erin

AU - Baxley, Catherine

AU - Canlas, Bernard R

AU - Pendleton, Tiffany

AU - Herbst, Ellen

AU - Batki, Steven

PY - 2023/3

Y1 - 2023/3

N2 - 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

AB - 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

KW - Acceptance and commitment therapy

KW - Chronic pain

KW - Medication for opioid use disorder (MOUD)

KW - Mindfulness-based relapse prevention

KW - Opioid use disorder

KW - Pain education

KW - Veterans

U2 - 10.1016/j.cct.2023.107096

DO - 10.1016/j.cct.2023.107096

M3 - Article

C2 - 36693589

VL - 126

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

M1 - 107096

ER -

Vowles KE, Witkiewitz K, Clarke E, Schmidt Z, Borsari B, Edwards KE et al. 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. Contemporary Clinical Trials. 2023 Mar;126:107096. Epub 2023 Feb 1. doi: 10.1016/j.cct.2023.107096