1. 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.
- Author
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Vowles, Kevin E, Witkiewitz, Katie, Clarke, Erik, Schmidt, Zachary, Borsari, Brian, Edwards, Karlyn E, Korecki, J Richard, Moniz-Lewis, David I, Bondzie, Juliana A, Mullins, Chloe, Thoreson, Claire I, Delacruz, Joannalyn, Wilkins, Consuelo H, Nelson, Sarah, Delventura, Jennifer, Henderson, Ryan, Katz, Andrea, Hua, William, Watson, Erin, Baxley, Catherine, Canlas, Bernard R, Pendleton, Tiffany, Herbst, Ellen, and Batki, Steven
- Subjects
Humans ,Opioid-Related Disorders ,Buprenorphine ,Analgesics ,Opioid ,Adult ,Aged ,Middle Aged ,Veterans ,Young Adult ,Chronic Pain ,Acceptance and Commitment Therapy ,Acceptance and commitment therapy ,Chronic pain ,Medication for opioid use disorder ,Mindfulness-based relapse prevention ,Opioid use disorder ,Pain education ,Pain Research ,Drug Abuse (NIDA only) ,Mental Health ,Prevention ,Clinical Trials and Supportive Activities ,Complementary and Integrative Health ,Substance Misuse ,Behavioral and Social Science ,Clinical Research ,Neurosciences ,Management of diseases and conditions ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,6.6 Psychological and behavioural ,7.1 Individual care needs ,Good Health and Well Being ,Mindfulness -based relapse prevention ,Medical and Health Sciences ,General Clinical Medicine ,Public Health - 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.
- Published
- 2023