Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Status:
Recruiting
Trial end date:
2026-09-22
Target enrollment:
Participant gender:
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). 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).
Phase:
Phase 3
Details
Lead Sponsor:
T. John Winhusen, PhD Theresa Winhusen, PhD
Collaborators:
National Institute on Drug Abuse (NIDA) The Emmes Company, LLC The EMMES Corporation