drugset / Trial / NCT04212065

Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women

NCT04212065 ↗

Phase 4 Withdrawn Ohio State University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a non-inferiority, open label, randomized trial of women on buprenorphine Medication Assisted Therapy for opioid use disorder in pregnancy.Patients will be randomized to either the long acting monthly subcutaneous SublocadeTM or to short acting sublingual Suboxone®.

Timeline

Start
2020-02-21
Primary completion
2020-09-01
Completion
2020-09-01

Outcome

Outcome not reported

Stopped: “closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Buprenorphine Other / unclassified 8 mg Subcutaneous
Comparator Buprenorphine Other / unclassified 300 mg Subcutaneous