Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study

Abstract

Opioid use disorder (OUD) and resulting opioid-related overdoses are significant contributors to maternal morbidity and mortality. Yet very few clinical trials focus on evaluating the efficacy of medications for OUD among pregnant populations. Understanding challenges to the recruitment and retention of pregnant participants with OUD in clinical trials and identifying effective strategies to overcome these barriers are urgently needed to help improve outcomes. The SUCCESSful recruitment and retention in a randomized controlled trial of pregnant participants with opioid use disorder (SUCCESS) study was conceptualized and designed by researchers from the Medication treatment for Opioid use disorder in expectant Mothers (MOMs) trial (NIH NIDA NCT03918850). The objective of the SUCCESS study is to identify strategies, facilitators, and barriers to recruiting and retaining pregnant and postpartum participants with OUD in the MOMs trial. The SUCCESS study entails (1) semi-structured interviews with researchers from all 13 MOMs sites, (2) focus groups with MOMs trial participants, and (3) a modified Delphi process to develop data-driven guidance for future clinical trials. This commentary describes the motivation to conduct this study, presents our conceptual framework and critical decision points in protocol development, and describes the proposed product of this study.