Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

Completed

Conditions studied: Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Drug Abuse in Pregnancy

In brief

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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).

Key facts

Study ID

NCT03911466

Run by

T. John Winhusen, PhD

People needed

97

Starts

2020-07-21

Expected to finish

2024-11-06

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older, up to 41. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)

Where it is running

• Gateway Community Services — Jacksonville, Florida, United States
• Massachusetts General Hospital HOPE Clinic — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of New Mexico Milagro Clinic — Albuquerque, New Mexico, United States
• University of Cincinnati Health Perinatal Addictions Program — Cincinnati, Ohio, United States
• CODA, Inc. — Portland, Oregon, United States
• Pregnancy Recovery Center at Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Utah SUPeRAD Clinic — Salt Lake City, Utah, United States
• Addiction Recovery Services (ARS), Swedish Medical Center — Seattle, Washington, United States
• Marshall Health MARC Program — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

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