Planning grant for a multi-site trial to examine the effectiveness of recovery community centers serving the most impactful communities to support persons using medications for opioid use disorder

To address the ongoing opioid epidemic, the U.S. Department of Health and Human Services (HHS) seeks to improve access to treatment and recovery services. Currently, the gold-standard treatment for opioid use disorder (OUD) is long-term treatment using FDA-approved medications (MOUDs). Early discontinuation of MOUD use represents a critical barrier to the effectiveness of MOUDs, as more than half of persons who start MOUD use discontinue it early. Approaches are needed that support persons initiating MOUD treatment to stay engaged in medication assisted recovery over the longer term. Recovery community centers (RCCs) are emerging as an important third component of recovery-oriented systems of care that, until recently, were comprised solely of professional treatment and mutual-help organizations. These centers provide a welcoming recovery-oriented environment for persons using MOUDs that provide a range of recovery-oriented, peer-delivered services over the long-term. Despite recent rapid large-scale investment in their growth, empirical data on the functioning and outcomes of RCCs are extremely limited. Critically needed is research that can speak to the effectiveness of RCCs. To address this need, and in line with RFA-DA-22-034’s use of the R34 Planning Grant mechanism, we propose to conduct three preparatory studies that can inform the design and logistics of a planned subsequent rigorous R01-level trial. Our proposal builds on two key strengths: (1) our existing and growing NIDA-funded infrastructure to advance the science on RCCs (R24 DA051988), which allowed us to build relationships with RCCs nationwide and gain insight into consensus around appropriate outcome measures, and (2) the existing relationships of the RCCs participating in this project with MOUD-providing clinics near them. Because Black Americans are most impacted by the opioid epidemic, both in terms of overdose deaths and engagement in addiction treatment and support services, our focus is on RCCs serving Black communities. Using a community-based participatory research approach, our aims are to provide insight into key components of the planned subsequent rigorous R01-level trial using three distinct lines of inquiry. Aim 1 is to conduct a (small, multi-site) naturalistic longitudinal study of MOUD clinic patients to provide insight into the appropriateness of study procedures, and to receive feedback on randomization procedures. Aim 2 is to conduct a (small, multi-site) pilot randomized clinical trial (RCT) comparing two randomized groups of persons engaged in MOUD clinical care: those who receive linkage to their nearby RCC vs. those who do not. Aim 3 widens the lens beyond the RCCs participating in Aims 1 and 2. Directors and front desk staff of MOUD-providing clinics near RCCs serving Black communities will be surveyed and interviewed to identify barriers to incorporating a potential RCC linkage into MOUD clinics’ standard clinical care models. Together, these three studies will guide the design of a large-scale subsequent R01 level RCT.