STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy

Abstract

High-dose, long-term opioid therapy (LtOT) is associated with risk for serious harms. Rapid opioid discontinuation may lead to increased pain, psychological distress, and illicit opioid use, but gradual, supported opioid taper may reduce these risks. We previously demonstrated that an opioid taper support and pain coping skills training intervention reduced opioid dose more than usual care (43% vs 19% dose reduction from baseline), with no increase in pain intensity and a significant reduction in activity interference. We aim to adapt and test this intervention in the Kaiser Permanente Washington healthcare system with STRategies to Improve Pain and Enjoy life (STRIPE, NCT03743402), a pragmatic, randomized trial. Our goal was to randomize 215 participants on moderate-high dose (≥40 morphine milligram equivalent/day) LtOT to either cognitive-behavioral therapy-based pain coping skills training involving 18 telephone sessions over 52 weeks with optional opioid taper support or usual care. Data are collected from electronic health records, claims, and self-report. The primary outcomes are mean daily opioid dose and the pain intensity, interference with enjoyment of life, and interference with general activity (PEG) score at 12 months (primary time point) and 6 months (secondary time point). Secondary outcomes include having ≥30% opioid dose reduction from baseline, and patient-reported problem opioid use, opioid-related difficulties, pain self-efficacy, opioid craving, global impression of change, and anxiety and depressive symptoms at 6 and 12 months. If effective, this treatment could reduce opioid exposure and associated risks to patients, families, and communities while offering patients an alternative for managing pain.