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

Opioid Use Disorder Clinical Trial

Official title:
Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women

Clinical Trial 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®.

Clinical Trial Description

Opioid use disorder increased among pregnant women in recent years, despite an overall decrease in the general population in the same time frame. Given the increased use of buprenorphine for opioid use disorder, it has now become the most commonly misused prescription opioid subtype. Untreated opioid use disorder is associated with worse maternal, fetal, and neonatal outcomes. To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04212065
Study type Interventional
Source Ohio State University
Contact
Status Withdrawn
Phase Phase 4
Start date February 21, 2020
Completion date September 1, 2020
View Details
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