Medication Treatment for Opioid Use Disorder in Expectant Mothers

Pregnancy Related Clinical Trial

— MOMs  

Official title:

Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03918850
• Other study ID #: 2019-0429-1
• Secondary ID: UG1DA013732
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 21, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Abuse
• Drug Abuse in Pregnancy
• Drug Addiction
• Neonatal Abstinence Syndrome
• Neonatal Opioid Withdrawal Syndrome
• Opioid-Related Disorders
• Pregnancy Related
• Substance Abuse
• Substance Withdrawal Syndrome
• Substance-Related Disorders
• Syndrome

Intervention

Drug:
• Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
• Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
T. John Winhusen, PhD	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Screening through delivery
Secondary	Total days of neonatal opioid treatment during the hospital stay	This outcome will be abstracted from the medical record.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	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.	Delivery through 12 months postpartum
Secondary	Proportion of days with study medication adherence	Adherence to treatment during pregnancy through 12 months postpartum	Screening through 12 months postpartum
Secondary	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.	Screening through 12 months postpartum
Secondary	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.	Screening through delivery
Secondary	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.	Delivery through 12 months postpartum
Secondary	Adequacy of Prenatal Care Utilization Index	The information will be derived from either medical records or the birth certificate.	At delivery
Secondary	Short Opiate Withdrawal Scale (SOWS)-Gossop	Measure of maternal opioid withdrawal symptoms.	Screening through 12 months postpartum
Secondary	Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms	Use of opioid medication for NOWS symptoms will be abstracted from the medical record.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	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)	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	Adjunct Medications	Use of adjunct medications (e.g., phenobarbital, clonidine) will be abstracted from the medical record.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	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.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)	A diagnosis code indicative of NOWS (Yes/No) will be abstracted from the medical record.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	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.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	Medications at discharge	Medications that the infant is to continue receiving at discharge will be abstracted from the medical record.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	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.	Neonate discharge from hospital, typically within 1 month postpartum
Secondary	Ages and Stages Questionnaire, third edition (ASQ-3)	To screen for developmental issues in the infant.	6 months postpartum
Secondary	Ages and Stages Questionnaire, third edition (ASQ-3)	To screen for developmental issues in the infant.	12 months postpartum