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

被引：2

作者：

Vowles, Kevin E. ^{[1
]}

Witkiewitz, Katie ^{[2
]}

Clarke, Erik ^{[3
]}

Schmidt, Zachary ^{[4
]}

Borsari, Brian ^{[5
,6
]}

Edwards, Karlyn E. ^{[7
]}

Korecki, J. Richard ^{[8
]}

Moniz-Lewis, David, I ^{[2
]}

Bondzie, Juliana A. ^{[3
]}

Mullins, Chloe ^{[4
]}

Thoreson, Claire, I ^{[3
]}

Delacruz, Joannalyn ^{[5
,6
]}

Wilkins, Consuelo H. ^{[9
]}

Nelson, Sarah ^{[9
]}

Delventura, Jennifer ^{[3
]}

Henderson, Ryan ^{[3
]}

Katz, Andrea ^{[3
]}

Hua, William ^{[5
,6
]}

Watson, Erin ^{[5
,6
]}

Baxley, Catherine ^{[5
,6
]}

Canlas, Bernard R. ^{[3
]}

Pendleton, Tiffany ^{[4
]}

Herbst, Ellen ^{[5
,6
]}

Batki, Steven ^{[5
,6
]}

机构：

[1] Queens Univ Belfast, Sch Psychol, Belfast, Antrim, North Ireland

[2] Univ New Mexico, Dept Psychol, Albuquerque, NM 87131 USA

[3] Puget Sound Vet Affairs Healthcare Adm, Tacoma, WA USA

[4] Raymond G Murphy Vet Affairs Med Ctr, New Mexico Vet Affairs Healthcare Syst, Albuquerque, NM USA

[5] San Francisco VA Med Ctr, San Francisco, CA USA

[6] Univ Calif San Francisco, San Francisco, CA 94143 USA

[7] Stanford Univ, Dept Anesthesiol Perioperat & Pain Med, Div Pain Med, Palo Alto, CA 94304 USA

[8] Univ Calif Los Angeles, Dept Psychol, Los Angeles, CA USA

[9] Vanderbilt Univ, Vanderbilt Inst Clin & Translat Res, 221 Kirkland Hall, Nashville, TN 37235 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2023年 / 126卷

基金：

美国国家卫生研究院;

关键词：

Chronic pain; Opioid use disorder; Medication for opioid use disorder (MOUD); Veterans; Acceptance and commitment therapy; Mindfulness -based relapse prevention; Pain education; CHRONIC NONCANCER PAIN; RELAPSE PREVENTION; UNITED-STATES; TIMELINE FOLLOWBACK; BACK-PAIN; ALCOHOL; ACCEPTANCE; ABUSE; PREVALENCE; HEALTH;

D O I：

10.1016/j.cct.2023.107096

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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

引用

页数：8

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