Completed

NCT Number: NCT03911466

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

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).

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Drug Abuse Drug Abuse in Pregnancy Drug Addiction Infant, Newborn, Diseases Mental Disorders Narcotic-Related Disorders Neonatal Abstinence Syndrome Neonatal Opioid Withdrawal Syndrome Pregnancy Related Substance Abuse Substance-Related Disorders

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Gateway Community Services, Jacksonville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Buprenorphine Injection

Drug

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

Other names: CAM2038

Buprenorphine Sublingual Product

Drug

Sublingual buprenorphine (BUP-SL), administered daily.

Other names: Subutex, Suboxone

Primary outcomes

Cmin of buprenorphine and metabolites in plasma

Time frame: 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.
Cmin of buprenorphine and metabolites in plasma

Time frame: 4 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

Time frame: Estimated gestational age (EGA) approximately 36 weeks

This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Cmin of buprenorphine and metabolites in plasma

Time frame: Estimated gestational age (EGA) approximately 36 weeks

A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Cmax of buprenorphine and metabolites in plasma

Time frame: 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

Time frame: 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

Time frame: Delivery

Cord blood will be collected and used to estimate fetal exposure to buprenorphine.

Sponsors and collaborators

Lead sponsor

T. John Winhusen, PhD

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MOMs-CMA

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2024
First posted: Apr 11, 2019
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed