Overview

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

Status:
Recruiting

Trial end date:
2026-09-22

Target enrollment:
0

Participant gender:
Female

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

T. John Winhusen, PhD
Theresa Winhusen, PhD

Collaborators:

National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
The EMMES Corporation

Treatments:

Buprenorphine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-