Clinical trial NCT03918850: Medication Treatment for Opioid Use Disorder in Expectant Mothers
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2019-04-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of illicit opioid-negative urine samples during pregnancy
timeFrame: Screening through delivery
Secondary outcomes:
measure: Total days of neonatal opioid treatment during the hospital stay
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Proportion of illicit opioid-negative urine samples postpartum
timeFrame: Delivery through 12 months postpartum
measure: Proportion of days with study medication adherence
timeFrame: Screening through 12 months postpartum
measure: Proportion of drug and alcohol-negative urine samples
timeFrame: Screening through 12 months postpartum
measure: Opioid Craving Scale
timeFrame: Screening through delivery
measure: Opioid Craving Scale
timeFrame: Delivery through 12 months postpartum
measure: Adequacy of Prenatal Care Utilization Index
timeFrame: At delivery
measure: Short Opiate Withdrawal Scale (SOWS)-Gossop
timeFrame: Screening through 12 months postpartum
measure: Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Infant Hospital Length of Stay
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Adjunct Medications
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Custody at discharge
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Medications at discharge
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Child protective services open case
timeFrame: Neonate discharge from hospital, typically within 1 month postpartum
measure: Ages and Stages Questionnaire, third edition (ASQ-3)
timeFrame: 6 months postpartum
measure: Ages and Stages Questionnaire, third edition (ASQ-3)
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital HOPE Clinic
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico Milagro Clinic
state: New Mexico
city: Cincinnati
country: United States
facility: University of Cincinnati Health Perinatal Addictions Program
state: Ohio
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
city: Pittsburgh
country: United States
facility: Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah SUPeRAD Clinic
state: Utah
city: Seattle
country: United States
facility: Addiction Recovery Services (ARS), Swedish Medical Center
state: Washington
city: Huntington
country: United States
facility: Marshall Health MARC Program
state: West Virginia
Study officials:
affiliation: University of Cincinnati
name: T. John Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References: