MedTrace Logo

Medication Treatment for Opioid Use Disorder in Expectant Mothers

NCT03918850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-06-27

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).

Conditions

  • Opioid-Related Disorders
  • Drug Addiction
  • Pregnancy Related
  • Substance Abuse
  • Drug Abuse
  • Neonatal Abstinence Syndrome
  • Neonatal Opioid Withdrawal Syndrome
  • Drug Abuse in Pregnancy

Interventions

DRUG

Buprenorphine Injection

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

DRUG

Buprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • T. John Winhusen, PhD

    lead OTHER

Principal Investigators

  • T. John Winhusen, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918850 on ClinicalTrials.gov