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Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs)

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

Eligibility Criteria

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

Inclusion Criteria:

Potential participants must:

  1. be 18-41 years of age
  2. be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA < 12 weeks and is not planning to terminate the pregnancy
  3. have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
  4. meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD
  5. be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits
  6. be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS
  7. be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
  8. be able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

Potential participants must not:

  1. have a physiological dependence on alcohol or sedatives requiring medical detoxification
  2. have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:

    • Suicidal or homicidal ideation requiring immediate attention
    • Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
  3. have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:

    • aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
    • serum creatinine greater than 1.5X upper limit of normal
    • total bilirubin greater than 1.5X upper limit of normal
  4. be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
  5. be currently receiving methadone or naltrexone for the treatment of OUD;
  6. be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;
  7. be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.

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

Proportion of illicit opioid-negative urine samples during pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.

Secondary Outcome Measures

Total days of neonatal opioid treatment during the hospital stay
This outcome will be abstracted from the medical record.
Proportion of illicit opioid-negative urine samples postpartum
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Proportion of days with study medication adherence
Adherence to treatment during pregnancy through 12 months postpartum
Proportion of drug and alcohol-negative urine samples
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites.
Opioid Craving Scale
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.
Opioid Craving Scale
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.
Adequacy of Prenatal Care Utilization Index
The information will be derived from either medical records or the birth certificate.
Short Opiate Withdrawal Scale (SOWS)-Gossop
Measure of maternal opioid withdrawal symptoms.
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
Infant Hospital Length of Stay
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (Infant)
Adjunct Medications
Use of adjunct medications (e.g., phenobarbital, clonidine) will be abstracted from the medical record.
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
NOWS peak score will be abstracted from the medical record. Because sites may use different NOWS scoring systems, the scoring system that was used will be included as part of the peak score abstraction.
Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)
A diagnosis code indicative of NOWS (Yes/No) will be abstracted from the medical record.
Custody at discharge
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record.
Medications at discharge
Medications that the infant is to continue receiving at discharge will be abstracted from the medical record.
Child protective services open case
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record.
Ages and Stages Questionnaire, third edition (ASQ-3)
To screen for developmental issues in the infant.
Ages and Stages Questionnaire, third edition (ASQ-3)
To screen for developmental issues in the infant.

Full Information

First Posted
April 9, 2019
Last Updated
September 25, 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
NCT03918850
Brief Title
Medication Treatment for Opioid Use Disorder in Expectant Mothers
Acronym
MOMs
Official Title
Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
Study Type
Interventional

2. Study Status

Record Verification Date
September 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
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
Detailed Description
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.
Masking
None (Open Label)
Masking Description
The primary outcome is assessed in a masked fashion by a central laboratory, but there is no masking for other outcomes.
Allocation
Randomized
Enrollment
140 (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
Proportion of illicit opioid-negative urine samples during pregnancy
Description
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Time Frame
Screening through delivery
Secondary Outcome Measure Information:
Title
Total days of neonatal opioid treatment during the hospital stay
Description
This outcome will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Proportion of illicit opioid-negative urine samples postpartum
Description
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Time Frame
Delivery through 12 months postpartum
Title
Proportion of days with study medication adherence
Description
Adherence to treatment during pregnancy through 12 months postpartum
Time Frame
Screening through 12 months postpartum
Title
Proportion of drug and alcohol-negative urine samples
Description
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites.
Time Frame
Screening through 12 months postpartum
Title
Opioid Craving Scale
Description
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.
Time Frame
Screening through delivery
Title
Opioid Craving Scale
Description
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving.
Time Frame
Delivery through 12 months postpartum
Title
Adequacy of Prenatal Care Utilization Index
Description
The information will be derived from either medical records or the birth certificate.
Time Frame
At delivery
Title
Short Opiate Withdrawal Scale (SOWS)-Gossop
Description
Measure of maternal opioid withdrawal symptoms.
Time Frame
Screening through 12 months postpartum
Title
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Description
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Infant Hospital Length of Stay
Description
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (Infant)
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Adjunct Medications
Description
Use of adjunct medications (e.g., phenobarbital, clonidine) will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
Description
NOWS peak score will be abstracted from the medical record. Because sites may use different NOWS scoring systems, the scoring system that was used will be included as part of the peak score abstraction.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)
Description
A diagnosis code indicative of NOWS (Yes/No) will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Custody at discharge
Description
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Medications at discharge
Description
Medications that the infant is to continue receiving at discharge will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Child protective services open case
Description
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record.
Time Frame
Neonate discharge from hospital, typically within 1 month postpartum
Title
Ages and Stages Questionnaire, third edition (ASQ-3)
Description
To screen for developmental issues in the infant.
Time Frame
6 months postpartum
Title
Ages and Stages Questionnaire, third edition (ASQ-3)
Description
To screen for developmental issues in the infant.
Time Frame
12 months postpartum

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: Potential participants must: be 18-41 years of age be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA < 12 weeks and is not planning to terminate the pregnancy have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable) meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake) be able to understand the study, and having understood, provide written informed consent in English Exclusion Criteria: Potential participants must not: have a physiological dependence on alcohol or sedatives requiring medical detoxification have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include: Suicidal or homicidal ideation requiring immediate attention Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder) have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal serum creatinine greater than 1.5X upper limit of normal total bilirubin greater than 1.5X upper limit of normal be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities; be currently receiving methadone or naltrexone for the treatment of OUD; be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed; be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.
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.
IPD Sharing URL
https://datashare.nida.nih.gov/

Learn more about this trial

Medication Treatment for Opioid Use Disorder in Expectant Mothers

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