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. Author manuscript; available in PMC: 2026 Feb 4.
Published in final edited form as: Subst Use Addctn J. 2025 Jul 11;46(4):1040–1046. doi: 10.1177/29767342251334490

Protocol commentary for the SUCCESS (Successful recruitment and retention in a randomized controlled trial of pregnant participants with opioid use disorder) study

Ashley M Snyder 1, Sanila Math 2, Kristine Campbell 3, Davida M Schiff 4, Alexindra Wheeler 4, Kristi Carlston 1, Adam J Gordon 1,5, T John Winhusen 6,7, Gerald Cochran 1,8,9, Marcela C Smid 1,10
PMCID: PMC12865609  NIHMSID: NIHMS2126483  PMID: 40643178

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 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 decisions points in protocol development, and describes the proposed product of this study.

Introduction

Drug-related deaths are a leading cause of maternal mortality,1–4 and trials for opioid use disorder (OUD) focused on perinatal populations are urgently needed to evaluate potentially life-saving interventions.5 Clinical trials with vulnerable populations, including those who are pregnant or have OUD, often struggle with recruitment and retention, with some trials closing early due to lack of recruitment or difficulty in participant retention.6–14 Barriers to research participation during pregnancy include study burden, distrust of research, and fear of risk, particularly to the fetus.15–19 These barriers are further exacerbated among the historically marginalized population of people with OUD, who face additional social and economic barriers to research participation.18,20,21 Successful strategies for recruitment and retention of pregnant participants include addressing resource scarcity (e.g. transportation barriers), transparency around benefits and risks of study participation, and designing procedures to ease study burdens.22 However, less understood is about how to tailor these strategies to pregnant participants with OUD, an exceptionally vulnerable population.

In this commentary, we present a brief narrative of the SUCCESSful recruitment and retention in a randomized controlled trial of pregnant participants with opioid use disorder (SUCCESS) protocol. In the SUCCESS study, interviews and focus groups are conducted with research team members and participants from the Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs) study (NCT03918850), a multi-center randomized controlled trial (RCT) of long-acting injectable (LAI) and sublingual buprenorphine.23 Qualitative data are analyzed to describe strategies, facilitators, and barriers to recruiting and retaining pregnant and postpartum participants with OUD. From these data, we will develop proposed guidelines for future studies using a modified Delphi process. More detail on the SUCCESS protocol is provided in the Supplementary File. The overarching goal of the SUCCESS study is to develop guidance for future clinical trials with pregnant participants with OUD. In this commentary, we describe the motivation for conducting this study, present our conceptual framework and critical decisions points in the protocol developed, and describe the proposed product of this study.

Where we have been

While some lessons may be extrapolated from clinical trials with pregnant participants and those with OUD, strategies to recruit and retain pregnant participants with OUD in interventional trials are not well understood. The Maternal Opioid Treatment: Human Experimental Research (MOTHER) trial, an RCT comparing methadone and buprenorphine among pregnant participants with OUD, is considered a seminal study for this population.24 This trial presented multiple administrative challenges and research decisions across the eight trial sites, such as staff turnover, data tracking, and statistical complications.25 Lessons learned from the MOTHER trial included the need for established treatment protocols, frequent meetings with multiple sites to address unanticipated barriers, and study design flexibility.25 These lessons from the MOTHER trial were incorporated into the MOMs study design. MOMs is an RCT comparing sublingual buprenorphine to weekly LAI in pregnant participants with OUD and with an estimated gestational age between 6–30 weeks at 13 sites across the US, with follow-up for 12 months postpartum.23 The SUCCESS study is designed to formally evaluate the experiences of research team members and trial participants and systematically capture facilitators and barriers of recruitment and retention among pregnant participants with OUD in the MOMs study.

Brief overview of SUCCESS specific aims

Aim 1 of SUCCESS is to identify strategies and challenges in recruitment and retention among the 13 sites from the MOMs trial through qualitative research. This objective is expected to produce a curated summary of site strategies, facilitators, barriers, and challenges for recruitment and retention of pregnant and postpartum participants with OUD and the association of those factors with observed enrollment. Aim 2 for this study is to elicit and review feedback about strategies and modifiable elements of the research environment with MOMs trial participants in focus groups. Finally, Aim 3 is to convene a modified Delphi process with MOMs site research team members and additional experts to develop data-informed guidelines and recommendations for strategies to optimize recruitment and retention of pregnant participants with OUD into clinical trials.

Conceptual framework

The SUCCESS study uses the Promoting Action on Research Implementation in Health Services (PARIHS) framework to understand how research strategies for recruitment and retention of vulnerable populations were implemented during the MOMs trial.26,27 The PARIHS framework provides a particularly useful and conceptual heuristic in understanding the complexities of the research environment at the local level (Figure 1). This framework captures the dynamic relationship of three domains of inquiry: evidence, context, and facilitation (Figure 1).27,28 We utilize these three domains when designing interview and focus group guides with questions regarding study interventions (LAI versus sublingual buprenorphine), context of each research site, and facilitation of the MOMs trial at each research site.28 Situated within the PARIHS framework, SUCCESS seeks to elicit research team members’ and participants’ procedural, interactive, and conditional reasoning (Table 1).

Figure 1:

Figure 1:

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Adaptation of Promoting Action on Research Implementation in Health Services framework28 to inform interview questions with study team members.

Table 1.

Examples of how research questions were developed to elicit participants’ reasoning about recruitment and retention in the MOMs trial using the Promoting Action on Research Implementation in Health Services (PARIHS) framework28

Type of reasoning Description Examples
Procedural Deductive and based on logical reasoning closely related to scientific knowledge regarding the diagnosis, prognosis, and symptoms • Researchers: Were there any challenges to administering medications to participants?
• MOMs trial participants: When you were first approached about the study, were you hoping to be randomized to one group or the other?
Interactive Narrative reasoning originating from an interpretive paradigm and is generally concerned with a participant’s experience of their condition and developing partnership • Researchers: How would you describe the culture of research with pregnant individuals with OUD at your site?
• MOMs trial participants: How do you feel about the number of times MOMs research staff reached out to you about the trial?
Conditional When procedural and interactive reasoning are integrated and the practitioner aims to understand the participant within their life-world, such as with context and time dimensions • Researchers: How, if at all, did child welfare services and policies affect recruitment and retention at your site?
• MOMs trial participants: Do you feel like MOMs staff needed a better understanding of what life is like for pregnant participants with opioid use disorder, and if so, what would you like them to understand?
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Justification for modified grounded theory

To analyze our data, we use a modified grounded theory for focus groups and interviews.29 This methodology allows study questions to evolve with the answers obtained from participants. The researcher interview guide contains questions regarding recruitment and retention factors and interactions with MOMs participants, such as trial advertising methods and institutional support. There are additional questions focusing on recruitment and retention specifically with participants of color. Interviews are analyzed at a midway point and again once all interviews are completed. Validity of results is assessed through method triangulation (comparing interview data to relevant MOMs trial documentation) and data triangulation (comparing across study sites). Interview results drive question development for the MOMs trial participant focus groups. The iterative process of grounded theory allows for data driven revisions of the initial interviews and identification of questions that need further elucidation in focus groups. This design is intended to ensure that the results of the SUCCESS study are rooted in the first-hand experiences of research team members and MOMs trial participants.

Integrating research team and MOMs trial participant voices

SUCCESS takes multiple steps to ensure that both the researcher and the participant perspectives are incorporated into the study process. Data from interviews with research team members and MOMs trial participants are integrated sequentially.30 Researchers are interviewed first to identify themes and subthemes that are expected to evolve as interviews and focus groups are conducted. Next, in focus groups, MOMs participants are asked about themes from interviews with research team members that need further input. MOMs participants can provide feedback rooted in their experiences to further identify context behind these themes.

Because interview and focus group guides are only semi-structured, additional questions can be asked to gather details on concepts that are new to them or that participants want to emphasize. This flexibility allows SUCCESS researchers to elevate the participant voice in data collection. In the development of SUCCESS protocol, MOMs clinicians and SUCCESS aimed to incorporate the participant voice in order to improve for future clinical trials. Understanding the experiences of both the people who conducted the study and those who were enrolled in MOMs is expected to guide the creation of a proposed set of best practices in clinical trials with pregnant participants with OUD in preparation for the final phase of the SUCCESS study.

Where we are going

Delphi panel to establish guidelines for future studies

The ultimate goal of the SUCCESS study is to create consensus guidelines for designing clinical trials with pregnant populations with OUD by using a modified Delphi process.31 After interviews and focus groups, we create a draft of potential strategies to optimize recruitment and retention of pregnant populations with OUD. MOMs research team members and experts in clinical trials with vulnerable populations, including pregnant patients, are invited to be panelists for the Delphi process. MOMs trial participants will be asked to provide expert review of results.

We use the modified Delphi process because it is a consensus-building technique that uses an iterative process of assessing individual participant opinion, statistical summaries of responses, and group feedback of anonymized summary statistics to achieve convergence of participants’ opinions around a question for which empirical evidence is unavailable.32–35 Strengths of the Delphi process include anonymity of participants and feedback of group responses and supporting convergence of opinion through normative processes.36 For this study, anonymity for MOMS research team members and expert panelists is particularly important as there may be a real or perceived hierarchy among MOMs research sites and trial participants.

In each round of the Delphi process, panelists are asked to rank strategies in terms of (1) importance for ensuring trial success and (2) feasibility of strategies in the research environment on a 9-point Likert scale. The purpose of this dual ranking is to identify both the importance of a strategy or element and the ability of research teams to modify their “real world” research environments to adopt high-priority strategies. Panel feedback related to strategies identified as high priority but lower feasibility will be examined separately to understand whether specific research environments may be more amenable to these strategies. Panelists are also encouraged to provide open-ended responses to questions to improve understanding of numeric ranking selections. After each round, investigators remove or revise suggested best practices. Consensus will be defined as 75% of panelists ranking the intervention as high priority. We will report the results of the feasibility of the best practice.

Limitations

We aim to capture and integrate researcher and pregnant participant perspectives. However, there are limitations to this approach and how it will be generalizable to other studies. Because we include sites from the MOMs study in multiple US states, results may include location-specific factors that do not apply to other institutions or locations outside of the Clinical Trials Network. Regarding trial participants, we are only able to recruit participants who agreed to participate in the MOMs trial. To mitigate this limitation, we will invite researchers with experience in clinical trial implementation, individuals with lived experience in pregnancy and OUD, and researchers who work with peripartum and other vulnerable populations to the Delphi panel. By including multiple voices, we aim to improve generalizability to other studies and minimize the bias in including only MOMs research team members and MOMs trial participants.

Supplementary Material

Supplemental Material SUCCESS Protocol Methods

Proposed product and future work.

To address the maternal mortality crisis in the US, safe and effective OUD treatment options are urgently needed. However, significant barriers to recruitment and retention of pregnant participants with OUD must be overcome to successfully complete clinical trials and create evidence-based approaches to improve outcomes. The SUCCESS study leverages qualitative methodology to incorporate MOMs research team members and trial participant perspectives in the development of consensus guidelines. The final product of the SUCCESS study will be expert consensus best practices guidelines for clinical trials involving pregnant participants with OUD. Future work can focus on implementing the evaluation of these best practices.

Highlights.

  • Little is understood about the facilitators and barriers to clinical trial participation for pregnant participants with opioid use disorder.

  • Using interviews with research team members and focus groups with trial participants, this study aims to understand recruitment and retention facilitators and barriers for a large multi-center interventional trial of pregnant participants with opioid use disorder.

  • A modified Delphi process will be used to develop data-driven guidance for key strategies for future clinical trials with pregnant participants with opioid use disorder.

FUNDING

This work was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Health through the NIH HEAL Initiative under award numbers UG1DA013732 to the University of Cincinnati (T. John Winhusen), UG1DA049444 (Adam Gordon and Gerald Cochran), UG1DA013727 (Kathleen Brady and Matthew Carpenter), UG1DA013720 (Jose Szapocznik, Daniel Feaster, and Lisa Metsch), and UG1DA049436 (Jane Liebschutz and Judith Feinberg), and UG1DA013714 (John Roll and Mary Hatch-Maillette). The Publications Committee of the National Drug Abuse Treatment Clinical Trials Network reviewed and gave approval for submission of this manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative.

DISCLOSURE

Unrelated to this work, Marcela Smid’s institution receives research funds supporting her time from Gilead Inc and Koko Medical and previously received funds from Organon Inc.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplemental Material SUCCESS Protocol Methods
NIHMS2126483-supplement-Supplemental_Material_SUCCESS_Protocol_Methods.docx (33.8KB, docx)

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