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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Opioid-Related Disorders; Substance Abuse; Drug Abuse; Drug Addiction; Neonatal Abstinence Syndrome; Drug Abuse in Pregnancy; Neonatal Opioid Withdrawal Syndrome
• Intervention / Treatment: Drug: Buprenorphine Injection; Drug: Buprenorphine Sublingual Product

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Frankie Kropp, MS; Phone Number: 513-585-8290; Email: kroppfb@ucmail.uc.edu
• Study Contact Backup: Name: Ben Kropp, MSLS; Phone Number: 513-585-8287; Email: kroppbn@ucmail.uc.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Gateway Community Services
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital HOPE Clinic
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Milagro Clinic
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Health Perinatal Addictions Program
  • Oregon
    • Portland, Oregon, United States, 97214
      • CODA, Inc.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah SUPeRAD Clinic
  • Washington
    • Seattle, Washington, United States, 98107
      • Addiction Recovery Services (ARS), Swedish Medical Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Health MARC Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BUP-XR; 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.).	Drug: Buprenorphine Injection; Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).; Other Names: CAM2038
Active Comparator: BUP-SL; 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.).	Drug: Buprenorphine Sublingual Product; Sublingual buprenorphine (BUP-SL), administered daily.; Other Names: Subutex; Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.	2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.	4 weeks post-randomization
Fetal heart rate variability	This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).	Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma	A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.	Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma	A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.	Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma	A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.	Delivery
Concentration of buprenorphine and metabolites in cord plasma	Cord blood will be collected and used to estimate fetal exposure to buprenorphine.	Delivery

Collaborators and Investigators

• Sponsor: T. John Winhusen, PhD
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC
• Investigators: Principal Investigator: T. John Winhusen, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pharmacokinetics; CTN-0080; clinical trials network; medication assisted treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Disease; Infant, Newborn, Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Syndrome; Opioid-Related Disorders; Substance Withdrawal Syndrome; Neonatal Abstinence Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 2019-0429-2; UG1DA013732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No