Medication Treatment for Opioid Use Disorder in Expectant Mothers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Drug Abuse
- Drug Abuse in Pregnancy
- Drug Addiction
- Neonatal Abstinence Syndrome
- Neonatal Opioid Withdrawal Syndrome
- Opioid Related Disorders
- Pregnancy Related
- Substance Abuse
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.Masking: None (Open Label)Masking Description: The primary outcome is assessed in a masked fashion by a central laboratory, but there is no masking for other outcomes.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 41 years
- Gender
- Only males
Description
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they ...
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.
Tracking Information
- NCT #
- NCT03918850
- Collaborators
- National Institute on Drug Abuse (NIDA)
- The Emmes Company, LLC
- Investigators
- Principal Investigator: Theresa Winhusen, PhD University of Cincinnati
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