Medication Treatment for Opioid Use Disorder in Expectant Mothers

Summary

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

Timeline

Start

2020-07-21

Primary completion

2025-01-31

Completion

2025-01-31

Publications

• Winhusen TJ, Lofwall MR, Kropp F, Lewis D, Smid MC, Young JL, Hodgkins C, Krans EE, Hansen Z, Wachman EM, Schiff DM, Guille C, Rudolf V, Chowdhury T, Leeman L, Lewis M, Matthews AG, Cochran G, King J, Wilder C, Rosa C. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):533-543. doi: 10.1001/jamainternmed.2026.0057.
• Krans EE, Lewis D, Douaihy A, Lofwall MR, Kropp F, Martin PR, Sanghani RS, Cottrell JN, Winhusen TJ. Cigarette use and smoking cessation goals among pregnant women with opioid use disorder. J Subst Use Addict Treat. 2025 Dec 20:209865. doi: 10.1016/j.josat.2025.209865. Online ahead of print.
• Cash E, Cochran G, Smid MC, Charles JE, Humiston G, Wei Y, Mauerman N, Carlston K, Broussard G, Sengpraseut B, Martin PR, Winhusen TJ. Overdose risk profiles in pregnancy: Latent class analysis of pregnant individuals with opioid use disorder. J Subst Use Addict Treat. 2025 Sep 25:209809. doi: 10.1016/j.josat.2025.209809. Online ahead of print.
• Snyder AM, Math S, Campbell K, Schiff DM, Wheeler A, Carlston K, Gordon AJ, Winhusen TJ, Cochran G, Smid MC. Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study. Subst Use Addctn J. 2025 Oct;46(4):1040-1046. doi: 10.1177/29767342251334490. Epub 2025 Jul 11.
• Winhusen TJ, Kropp F, Greenfield SF, Krans EE, Lewis D, Martin PR, Gordon AJ, Davies TH, Wachman EM, Douaihy A, Parker K, Xin X, Jalali A, Lofwall MR. Trauma Prevalence and Its Association With Health-related Quality of Life in Pregnant Persons With Opioid Use Disorder. J Addict Med. 2025 Jan-Feb 01;19(1):20-25. doi: 10.1097/ADM.0000000000001366. Epub 2024 Aug 6.
• Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.

Drugs

Indications