Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical - Report - MDSpire

Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical

  • By

  • T. John Winhusen

  • Michelle R. Lofwall

  • Frankie Kropp

  • Daniel Lewis

  • Marcela C. Smid

  • Jessica L. Young

  • Candace Hodgkins

  • Elizabeth E. Krans

  • Zachary Hansen

  • Elisha M. Wachman

  • Davida M. Schiff

  • Constance Guille

  • Vania Rudolf

  • Tara Chowdhury

  • Lawrence Leeman

  • Mitra Lewis

  • Abigail G. Matthews

  • Gerald Cochran

  • Jacquie King

  • Christine Wilder

  • Carmen Rosa

  • May 1, 2026

  • 0 min

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Clinical Report: Extended-Release vs Sublingual Buprenorphine in Pregnancy

Overview

This randomized clinical trial evaluates the effectiveness and safety of extended-release buprenorphine compared to sublingual buprenorphine in pregnant individuals with opioid use disorder (OUD). The findings suggest that extended-release buprenorphine may offer higher rates of illicit opioid abstinence during pregnancy.

Background

Opioid use disorder (OUD) poses significant risks during pregnancy, necessitating effective treatment options. Sublingual buprenorphine is commonly used but has limitations, including adherence issues and potential for misuse. Extended-release buprenorphine may address these challenges, yet concerns about fetal exposure remain.

Data Highlights

No numerical data available in the provided material.

Key Findings

  • Extended-release buprenorphine demonstrated higher rates of illicit opioid abstinence compared to sublingual buprenorphine.
  • The trial included pregnant individuals aged 18 to 41 years with moderate to severe OUD.
  • Participants were randomized 1:1 to receive either extended-release or sublingual buprenorphine.
  • The study was conducted across 13 US sites, emphasizing collaborative care models.
  • Inclusion criteria ensured participants were eligible for buprenorphine treatment and planned delivery at appropriate facilities.

Clinical Implications

Healthcare providers should consider the potential benefits of extended-release buprenorphine in managing OUD during pregnancy, particularly regarding adherence and abstinence rates. Ongoing monitoring of fetal exposure and maternal health is essential when implementing this treatment.

Conclusion

The trial highlights the potential of extended-release buprenorphine as a viable option for treating OUD in pregnant individuals, warranting further investigation into its long-term effects and safety profiles.

References

  1. JAMA Internal Medicine, 2026 -- Error in Conclusions
  2. JAMA Internal Medicine, 2026 -- Errors in Table 1, Table 4, and Supplement 2
  3. Pain Medicine, 2023 -- Insights on: The Use of Buprenorphine for Managing Acute Pain in Elderly Patients: A Systematic Review and Meta-Analysis
  4. Opioid Use Disorder and Pregnancy | ACOG
  5. First Trimester Use of Buprenorphine or Methadone and the Risk of Congenital Malformations | JAMA Internal Medicine
  6. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial - PMC
  7. Open Forum Infectious Diseases — Monthly Administration of Long-Acting Cabotegravir/Rilpivirine for HIV Management in Pregnant Patients: A Case Report Series
  8. Opioid Use Disorder and Pregnancy | ACOG
  9. First Trimester Use of Buprenorphine or Methadone and the Risk of Congenital Malformations | Neonatology | JAMA Internal Medicine | JAMA Network
  10. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial - PMC

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