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

NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03911466

Acronym

MOMs-CMA

Enrollment

Registered

2019-04-11

Start date

2020-07-21

Completion date

2024-11-06

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics

Brief 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).

Interventions

DRUGBuprenorphine Injection

Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).

DRUGBuprenorphine Sublingual Product

Sublingual buprenorphine (BUP-SL), administered daily.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 41 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Cmin of buprenorphine and metabolites in plasma	2 weeks post-randomization	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Fetal heart rate variability	Estimated gestational age (EGA) approximately 36 weeks	This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Cmax of buprenorphine and metabolites in plasma	Estimated gestational age (EGA) approximately 36 weeks	A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Concentration of buprenorphine and metabolites in maternal plasma	Delivery	A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Concentration of buprenorphine and metabolites in cord plasma	Delivery	Cord blood will be collected and used to estimate fetal exposure to buprenorphine.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORT. John Winhusen, PhD

University of Cincinnati

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026