NCT03911739

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): Infant Neurodevelopmental Outcomes (INO) Sub-study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: T. John Winhusen, PhD · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.

Conditions

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

Interventions

Type	Name	Description
DRUG	Buprenorphine Injection	Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
DRUG	Buprenorphine Sublingual Product	Sublingual buprenorphine (BUP-SL), administered daily.

Timeline

• Start date: 2021-06-14
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2019-04-11
• Last updated: 2026-03-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study