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

Primary Purpose

Opioid-Related Disorders, Drug Addiction, Pregnancy Related

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine Injection
Buprenorphine Sublingual Product
Sponsored by
T. John Winhusen, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics

Eligibility Criteria

18 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Gateway Community Services
  • Massachusetts General Hospital HOPE Clinic
  • Boston Medical Center
  • University of New Mexico Milagro Clinic
  • University of Cincinnati Health Perinatal Addictions Program
  • CODA, Inc.
  • Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • University of Utah SUPeRAD Clinic
  • Addiction Recovery Services (ARS), Swedish Medical Center
  • Marshall Health MARC Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BUP-XR

BUP-SL

Arm Description

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.).

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.).

Outcomes

Primary Outcome Measures

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.
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.
Fetal heart rate variability
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
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.
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.
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.
Concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2019
Last Updated
October 12, 2023
Sponsor
T. John Winhusen, PhD
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03911466
Brief Title
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Acronym
MOMs-CMA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
T. John Winhusen, PhD
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Drug Abuse in Pregnancy
Keywords
CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUP-XR
Arm Type
Experimental
Arm Description
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.).
Arm Title
BUP-SL
Arm Type
Active Comparator
Arm Description
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.).
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Injection
Other Intervention Name(s)
CAM2038
Intervention Description
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Sublingual Product
Other Intervention Name(s)
Subutex, Suboxone
Intervention Description
Sublingual buprenorphine (BUP-SL), administered daily.
Primary Outcome Measure Information:
Title
Cmin of buprenorphine and metabolites in plasma
Description
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time Frame
2 weeks post-randomization
Title
Cmin of buprenorphine and metabolites in plasma
Description
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time Frame
4 weeks post-randomization
Title
Fetal heart rate variability
Description
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Time Frame
Estimated gestational age (EGA) approximately 36 weeks
Title
Cmin of buprenorphine and metabolites in plasma
Description
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Time Frame
Estimated gestational age (EGA) approximately 36 weeks
Title
Cmax of buprenorphine and metabolites in plasma
Description
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Time Frame
Estimated gestational age (EGA) approximately 36 weeks
Title
Concentration of buprenorphine and metabolites in maternal plasma
Description
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Time Frame
Delivery
Title
Concentration of buprenorphine and metabolites in cord plasma
Description
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Time Frame
Delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participating in the MOMs trial (Unique protocol ID: 2019-0429-1) Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. John Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Community Services
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Massachusetts General Hospital HOPE Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of New Mexico Milagro Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of Cincinnati Health Perinatal Addictions Program
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
CODA, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah SUPeRAD Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Addiction Recovery Services (ARS), Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Marshall Health MARC Program
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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