Study Protocol for Pain Self-Management and Patient-Oriented Buprenorphine Dosing for Pain and Retention in Office-Based Opioid Treatment: A Hybrid Type 1, 2 × 2 Factorial Randomized Controlled Trial.

Chronic pain is a significant factor for patients with opioid use disorder (OUD) contributing to suboptimal retention in buprenorphine treatment, which is a crucial predictor of long-term health outcomes. This study aims to address the critical need for effective interventions targeting chronic pain management within office-based opioid treatment (OBOT) programs. We are conducting a multisite, hybrid type 1, 2 × 2 factorial randomized clinical trial to determine the effectiveness of 2 novel interventions, pain self-management (PSM) and patient-oriented buprenorphine dosing (POD), to decrease pain interference and improve retention in buprenorphine treatment. PSM, a manualized and customizable approach delivered through individual and peer-led group sessions, aims to decrease pain-related symptoms and quality of life. POD involves split dosing of buprenorphine to extend the duration of analgesia to better match its duration of efficacy at managing OUD symptoms, leading to improved retention in buprenorphine treatment. Eligible participants will be randomized into 1 of 4 groups: (1) PSM + POD, (2) PSM + Standard Buprenorphine Dosing, (3) Usual Care + POD, or (4) Usual Care + Standard Buprenorphine Dosing. Usual Care refers to usual care for chronic pain and Standard Buprenorphine Dosing refers to the participant's current dosing regimen. Secondary objectives encompass overall pain reduction, decreased opioid use, improved pain symptom management, and exploration of implementation strategies. The supplemental approved protocol provides comprehensive insights into the procedures and variables being investigated. As part of the HEAL Initiative®-funded Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) network, this study aims to fill gaps in behavioral and medication treatments for individuals with co-occurring chronic pain and OUDs, improving pain management and retention in care. Successful outcomes from this trial may inform future larger trials, offering essential evidence for implementation considerations and reimbursement decisions.

Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial.

Importance: Prescription opioids can treat acute pain in primary care but have potential for unsafe use and progression to prolonged opioid prescribing. Objective: To compare clinician-facing interventions to prevent unsafe opioid prescribing in opioid-naive primary care patients with acute noncancer pain. Design Setting and Participants: We conducted a multisite, cluster-randomized, 2 × 2 factorial, clinical trial in 3 health care systems that comprised 48 primary care practices and 525 participating clinicians from September 2018 through January 2021. Patient participants were opioid-naive outpatients, 18 years or older, who presented for a qualifying clinic visit with acute noncancer musculoskeletal pain or nonmigraine headache. Interventions: Practices randomized to: (1) control; (2) opioid justification; (3) monthly clinician comparison emails; or (4) opioid justification and clinician comparison. All groups received opioid prescribing guidelines via the electronic health record at the time of a new opioid prescription. Main Outcomes and Measures: Primary outcome measures were receipt of an initial opioid prescription at the qualifying clinic visit. Other outcomes were opioid prescribing for more than 3 months and a concurrent opioid/benzodiazepine prescription over 12-month follow-up. Results: Among 22 616 enrolled patient participants (9740 women [43.1%]; 64 American Indian/Alaska Native [0.3%]; 590 Asian [2.6%], 1120 Black/African American [5.0%], 1777 Hispanic [7.9%], 225 Native Hawaiian/Pacific Islander [1.0%], and 18 981 White [83.9%] individuals), the initial opioid prescribing rates at the qualifying clinic visit were 3.1% in the total sample, 4.2% in control, 3.6% in opioid justification, 2.6% in clinician comparison, and 1.9% in opioid justification and clinician comparison. Compared with control, the adjusted odds ratio (aOR) for a new opioid prescription was 0.74 (95% CI, 0.46-1.18; P = .20) for opioid justification and 0.60 (95% CI, 0.38-0.96; P = .03) for clinician comparison. Compared with control, clinician comparison was associated with decreased odds of opioid therapy of more than 3 months (aOR, 0.79; 95% CI, 0.69-0.91; P = .001) and concurrent opioid/benzodiazepine prescription (aOR, 0.85; 95% CI, 0.72-1.00; P = .04), whereas opioid justification did not have a significant effect. Conclusions and Relevance: In this cluster randomized clinical trial, comparison emails decreased the proportion of opioid-naive patients with acute noncancer pain who received an opioid prescription, progressed to treatment with long-term opioid therapy, or were exposed to concurrent opioid and benzodiazepine therapy. Health care systems can consider adding clinician-targeted nudges to other initiatives as an efficient, scalable approach to further decrease potentially unsafe opioid prescribing. Trial Registration: ClinicalTrials.gov Identifier: NCT03537573.