Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical - Scorecard - 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 Scorecard: Comparative Study of Extended-Release and Sublingual Buprenorphine in Pregnant Individuals Through 12 Months Postpartum: A Randomized Clinical Trial

At a Glance

CategoryDetail
ConditionOpioid Use Disorder (OUD) in pregnant individuals
Key MechanismsExtended-release buprenorphine aims to reduce risks of diversion, misuse, and poor adherence associated with sublingual buprenorphine.
Target PopulationPregnant individuals aged 18-41 with moderate or severe OUD.
Care SettingGeographically varied clinical settings with collaborative care models.

Key Highlights

  • Extended-release buprenorphine demonstrated superior illicit opioid abstinence compared to sublingual buprenorphine.
  • Study conducted across 13 US sites with a focus on prenatal care and addiction treatment collaboration.
  • Participants attended weekly visits through 12 months postpartum.

Guideline-Based Recommendations

Diagnosis

  • Use DSM-5 criteria for diagnosing moderate or severe OUD.

Management

  • Consider extended-release buprenorphine for pregnant individuals to improve adherence and reduce cravings.

Monitoring & Follow-up

  • Weekly urine drug screens to assess illicit opioid use during pregnancy.

Risks

  • Monitor for higher fetal buprenorphine exposure with extended-release formulation.

Patient & Prescribing Data

Pregnant individuals with a singleton pregnancy and OUD.

Target doses are 16 mg/d for sublingual buprenorphine or 24 mg weekly for extended-release buprenorphine.

Clinical Best Practices

  • Implement written NOWS management protocols in hospitals.
  • Ensure rooming-in for infants observed for NOWS.
  • Avoid discharging infants receiving opioid treatment.

References

Original Source(s)

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

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