Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions (MOTHER DYAD)

Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes

This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; Neonatal Abstinence Syndrome; Opioid Withdrawal; Neonatal Opioid Withdrawal Syndrome
• Intervention / Treatment: Other: Medically-supervised withdrawal; Behavioral: Comprehensive clinical care; Other: Opioid agonist treatment

Detailed Description

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Mountain Area Health Education Center
    • Chapel Hill, North Carolina, United States, 27510
      • UNC Chapel Hill Horizons
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women seeking treatment for opioid use disorder

Description

Inclusion Criteria:

• Be ages 18 to 41, inclusive
• Have a single fetus pregnancy between 6-30 weeks estimated gestational age
• Willing to participate in the study

Exclusion Criteria:

• Non-English speaking

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medically-supervised withdrawal (MSW)	Other: Medically-supervised withdrawal; 6-8 day withdrawal with buprenorphine/naloxone; Other Names: Detoxification; Behavioral: Comprehensive clinical care; Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Opioid agonist treatment (OAT)	Behavioral: Comprehensive clinical care; Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening; Other: Opioid agonist treatment; Induction and maintenance with buprenorphine/naloxone; Other Names: Maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mothers who discontinued 1st treatment choice prior to delivery		Antepartum period
Proportion of mothers engaged in treatment at delivery	Behavior health treatment or medical treatment in past 21 days	Antepartum period
Proportion of mothers with illicit substance use at delivery	Positive vs. negative for any illicit substance in the urine	At delivery
Proportion of mother-child dyads with delivery complications	Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining	At delivery
Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)	Yes vs. no	At hospital discharge, an average of 10 days after delivery
Total average amount of medication given to treat NAS	Morphine Equivalent Dose in mg	At hospital discharge, an average of 10 days after delivery
Total average length of neonatal hospital stay	Days	At hospital discharge, an average of 10 days after delivery

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: National Institute on Drug Abuse (NIDA); Johns Hopkins University; University of North Carolina, Chapel Hill; Virginia Commonwealth University; Mountain Area Health Education Center
• Investigators: Principal Investigator: Sarah H Heil, PhD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Infant, Newborn, Diseases; Narcotic-Related Disorders; Syndrome; Opioid-Related Disorders; Substance Withdrawal Syndrome; Neonatal Abstinence Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: STUDY00000166; R01DA047867 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No