NCT04049799

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

4.5 years

First QC Date

July 23, 2019

Last Update Submit

February 6, 2024

Conditions

Opioid-use DisorderOpioid WithdrawalNeonatal Abstinence SyndromeNeonatal Opioid Withdrawal Syndrome

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Medically-supervised withdrawal (MSW)

Other: Medically-supervised withdrawalBehavioral: Comprehensive clinical care

Opioid agonist treatment (OAT)

Other: Opioid agonist treatmentBehavioral: Comprehensive clinical care

Interventions

Medically-supervised withdrawalOTHER

6-8 day withdrawal with buprenorphine/naloxone

Also known as: Detoxification
Medically-supervised withdrawal (MSW)
Opioid agonist treatmentOTHER

Induction and maintenance with buprenorphine/naloxone

Also known as: Maintenance
Opioid agonist treatment (OAT)
Comprehensive clinical careBEHAVIORAL

Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening

Medically-supervised withdrawal (MSW)Opioid agonist treatment (OAT)

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women seeking treatment for opioid use disorder

You may qualify if:

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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mountain Area Health Education Center

Asheville, North Carolina, 28803, United States

Location

UNC Chapel Hill Horizons

Chapel Hill, North Carolina, 27510, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersNeonatal Abstinence Syndrome

Interventions

Inactivation, MetabolicMaintenance

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BiotransformationMetabolismPharmacokineticsPharmacological and Toxicological PhenomenaPhysiological PhenomenaHealth Care Facilities Workforce and Services

Study Officials

  • Sarah H Heil, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2019

First Posted

August 8, 2019

Study Start

August 8, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

US(4)