Design of CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses)
A Randomized Trial of Collaborative Care for Opioid Use Disorder and Co-Occurring Depression And/Or Posttraumatic Stress Disorder
Published in: Contemporary Clinical Trials, Volume 104 (May 2021). doi: 10.1016/j.cct.2021.106354
Posted on RAND.org on March 10, 2023
Opioid use disorder (OUD) co-occurring with depression and/or posttraumatic stress disorder (PTSD) is common and, if untreated, may lead to devastating consequences. Despite the availability of evidence-based treatments for these disorders, receipt of treatment is low. Even when treatment is provided, quality is variable. Primary care is an important and underutilized setting for treating co-occurring disorders (COD) because OUD, depression and PTSD are frequently co-morbid with medical conditions and most people visit a primary care provider at least once a year. With rising rates of OUD and opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population.
CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) is a multi-site, randomized pragmatic trial of collaborative care (CC) for co-occurring disorders in 13 rural and urban primary care clinics in New Mexico to improve care for patients with OUD and co-occurring depression and/or PTSD. CC, a service delivery approach that uses multi-faceted interventions, has not been tested with COD. We will enroll and randomize 900 patients to either CC adapted for COD (CC-COD) or enhanced usual care (EUC) and will collect patient data at baseline, 3-, and 6-month follow-up. Our primary outcomes are medications for OUD (MOUD) access, MOUD continuity of care, depression symptoms, and PTSD symptoms.
Although CC is effective for improving outcomes in primary care among patients with mental health conditions, it has not been tested for COD. This article describes the CLARO CC-COD intervention and clinical trial.