NCT04212065

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

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®.

Detailed 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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	buprenorphine	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.

Timeline

• Start date: 2020-02-21
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-12-26
• Last updated: 2020-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study