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Completed

NCT Number: NCT04049799

Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Narcotic-Related Disorders Neonatal Abstinence Syndrome Neonatal Opioid Withdrawal Syndrome Opioid Withdrawal Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Mountain Area Health Education Center, Asheville, North Carolina, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medically-supervised withdrawal

Other

6-8 day withdrawal with buprenorphine/naloxone

Other names: Detoxification

Opioid agonist treatment

Other

Induction and maintenance with buprenorphine/naloxone

Other names: Maintenance

Comprehensive clinical care

Behavioral

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

Primary outcomes

  1. Proportion of mothers who discontinued 1st treatment choice prior to delivery

    Time frame: Antepartum period

  2. Proportion of mothers engaged in treatment at delivery

    Time frame: Antepartum period

    Behavior health treatment or medical treatment in past 21 days

  3. Proportion of mothers with illicit substance use at delivery

    Time frame: At delivery

    Positive vs. negative for any illicit substance in the urine

  4. Proportion of mother-child dyads with delivery complications

    Time frame: At delivery

    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

  5. Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)

    Time frame: At hospital discharge, an average of 10 days after delivery

    Yes vs. no

  6. Total average amount of medication given to treat NAS

    Time frame: At hospital discharge, an average of 10 days after delivery

    Morphine Equivalent Dose in mg

  7. Total average length of neonatal hospital stay

    Time frame: At hospital discharge, an average of 10 days after delivery

    Days

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Johns Hopkins University
  • Mountain Area Health Education Center
  • National Institute on Drug Abuse (NIDA)
  • University of North Carolina, Chapel Hill
  • Virginia Commonwealth University

Registry information

Official study title

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

Acronym: MOTHER DYAD

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2019
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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