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

Phase 3

Completed

• Conditions: Opioid-Related Disorders; Pregnancy Related; Drug Addiction; Substance Abuse; Drug Abuse; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome; Drug Abuse in Pregnancy
• Interventions: Drug: Buprenorphine Sublingual Product; Drug: Buprenorphine Injection

• Registration Number: NCT03911466
• Lead Sponsor: T. John Winhusen, PhD

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Study Start: 2020-07-21
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUP-SL	Buprenorphine Sublingual Product	Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
BUP-XR	Buprenorphine Injection	Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).

Primary Outcome Measures

Name	Time	Method
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.
Cmin of buprenorphine and metabolites in plasma	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.
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 cord plasma	Delivery	Cord blood will be collected and used to estimate fetal exposure to buprenorphine.

Trial Locations

Locations (12)

Gateway Community Services; 🇺🇸 Jacksonville, Florida, United States

Massachusetts General Hospital HOPE Clinic; 🇺🇸 Boston, Massachusetts, United States

Addiction Recovery Services (ARS), Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

University of Cincinnati Health Perinatal Addictions Program; 🇺🇸 Cincinnati, Ohio, United States

University of New Mexico Milagro Clinic; 🇺🇸 Albuquerque, New Mexico, 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

Marshall Health MARC Program; 🇺🇸 Huntington, West Virginia, United States

University of Utah SUPeRAD Clinic; 🇺🇸 Salt Lake City, Utah, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States