Medication Treatment for Opioid Use Disorder in Expectant Mothers

T. John Winhusen, PhD140 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 41 Years

Medical Language ↔ Plain English

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.

Locations (12)

Gateway Community Services

Jacksonville, Florida, United States

Massachusetts General Hospital HOPE Clinic

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

University of New Mexico Milagro Clinic

Albuquerque, New Mexico, United States

University of Cincinnati Health Perinatal Addictions Program

Cincinnati, Ohio, 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

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Utah SUPeRAD Clinic

Salt Lake City, Utah, United States

...and 2 more locations

Outcomes

Primary Outcomes

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.

Time frame: Screening through delivery

Secondary Outcomes

Total days of neonatal opioid treatment during the hospital stay

This outcome will be abstracted from the medical record.

Time frame: Neonate discharge from hospital, typically within 1 month postpartum

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.

Time frame: Delivery through 12 months postpartum

Proportion of days with study medication adherence

Adherence to treatment during pregnancy through 12 months postpartum

Time frame: Screening 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.

Time frame: Screening through 12 months postpartum

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.

Time frame: Screening through delivery

Opioid Craving Scale

Time frame: Delivery through 12 months postpartum

Adequacy of Prenatal Care Utilization Index

The information will be derived from either medical records or the birth certificate.

Time frame: At delivery

Short Opiate Withdrawal Scale (SOWS)-Gossop

Measure of maternal opioid withdrawal symptoms.

Time frame: Screening through 12 months postpartum

Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms

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

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)

Time frame: Neonate discharge from hospital, typically within 1 month postpartum

Adjunct Medications

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

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.

Time frame: Neonate discharge from hospital, typically within 1 month postpartum

Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)

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

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.

Time frame: Neonate discharge from hospital, typically within 1 month postpartum

Medications at discharge

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

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.

Time frame: Neonate discharge from hospital, typically within 1 month postpartum

Ages and Stages Questionnaire, third edition (ASQ-3)

To screen for developmental issues in the infant.

Time frame: 6 months postpartum

Ages and Stages Questionnaire, third edition (ASQ-3)

To screen for developmental issues in the infant.

Time frame: 12 months postpartum

Medication Treatment for Opioid Use Disorder in Expectant Mothers

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes