CTN-0080-A-2: Promoting Research with Mothers receiving OUD Treatment; a focus on Equity (PRoMOTE)
Davida Schiff, MD
Principal Investigator
Massachusetts General Hospital
Harvard Medical School
Davida.Schiff@mgh.harvard.edu
The purpose of this study is to prioritize and elevate the voices of women of color who have opioid use disorder (OUD) and are enrolled in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN)-0080 Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs) trial. The study will qualitatively explore the perspectives of CTN-0080 participants of color and triangulate findings with interviews of research staff to explore drivers of trial enrollment and treatment adherence. The study will apply mixed-methods to investigate facilitators and barriers to treatment initiation of medications to treat opioid use disorder (MOUD), trial engagement, and study retention in CTN-0080, with a focus on race, racism, and equity. The study will also triangulate interview responses with individual-, site-, and state-level characteristics to identify opportunities for intervention to address stigma, discrimination, and racism in perinatal substance use disorder (SUD) care at individual, interpersonal, and structural levels.
Related Studies
- CTN-0080: Medication Treatment for Opioid-dependent Expecting Mothers (MOMs): A Pragmatic Randomized Trial Comparing Two Buprenorphine Formulations (NIH HEAL Initiative)
- CTN-0080-A-1: Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant People with Opioid Use Disorder (SUCCESS STUDY)
- CTN-0080-A-3: Improved Messaging Strategies for MOUD for Underserved Populations of Pregnant and Postpartum Individuals with OUD
Primary Findings
Facilitators of successful engagement in the MOMs trial and retention in medication treatment among pregnant and postpartum people of color with OUD included non-judgmental care, sustained trust, and frequent contact. Key perinatal OUD clinical interventions and trial improvements include personalized communication and scheduling flexibility to promote engagement of marginalized populations.
Primary Outcomes Article: Wheeler A, et al. Experiences of pregnant and postpartum people of color engaged in a randomized clinical trial of medication to treat opioid use disorder during pregnancy: A “Positive Outliers” analysis. Journal of Substance Use and Addiction Treatment 2026 (in press). [doi: 10.1016/j.josat.2026.209988]
Related Resources
Node Involvement
Lead Node(s):