NCT04049799

Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 88 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

Detailed description

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Conditions

• Opioid-use Disorder
• Opioid Withdrawal
• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal Syndrome

Interventions

Type	Name	Description
OTHER	Medically-supervised withdrawal	6-8 day withdrawal with buprenorphine/naloxone
OTHER	Opioid agonist treatment	Induction and maintenance with buprenorphine/naloxone
BEHAVIORAL	Comprehensive clinical care	Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening

Timeline

• Start date: 2019-08-08
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2019-08-08
• Last updated: 2024-02-08

Locations

4 sites across 1 country: United States